Part 16: Templates and Context Groups



Digital Imaging and Communications in Medicine (DICOM)

Supplement 50: Mammography Computer-Aided Detection SR SOP Class

Status: Draft 19 – June 28, 2000 (Public Comment)

DICOM Standards Committee

1300 N. 17th Street

Rosslyn, Virginia 22209 USA

Table of Contents

Table of Contents 2

Foreword 5

Scope and Field of Application 6

OPEN ISSUES 6

Part 3, Annex A Addendum 8

A.X Structured REPORT Document Information Object Definitions 8

A.X.1 CAD SR Information Object Definition 8

A.X.1.1 Mammography CAD SR Information Object Description 8

A.X.1.2 Mammography CAD SR IOD Entity-Relationship Model 8

A.X.1.3 Mammography CAD SR IOD Module Table 8

A.X.1.3.1 Mammography CAD SR IOD Content Constraints 9

A.X.1.3.1.1 Template Identification 9

A.X.1.3.1.2 Value Type 9

A.X.1.3.1.3 Relationship Constraints 9

Part 3, Annex X Addendum 11

ANNEX X (INFORMATIVE) 11

X.1 Mammography CAD SR Content Tree Structure 11

X.2 Mammography CAD SR Observation Context Encoding 13

X.3 Mammography CAD SR Examples 14

Example 1: Calcification and Mass Detection with No Findings 14

Example 2: Calcification and Mass Detection with Findings 16

Example 3: Calcification and Mass Detection, Temporal Differencing with Findings 20

Part 4 Addendum 30

B.5 Standard SOP Classes 30

B.5.1.5 Structured Reporting Storage SOP Classes 30

I.4 MEDIA STANDARD STORAGE SOP Classes 30

O.2.x Mammography CAD SR SOP Class 30

O.4.1.x Mammography CAD SR SOP Class 30

O.4.2.x Mammography CAD SR SOP Class 31

Part 6 Addendum 32

Annex A (Normative): Registry of DICOM Unique Identifiers (UID) 32

Part 16 Addendum 33

Annex X: MAMMOGRAPHY CAD SR IOD TEMPLATES 33

TID nnn1 Mammography CAD SR IOD Document Root Template 34

Content Item Descriptions 35

TID nnn2 Mammography CAD SR IOD Overall Impression/Recommendation Template 35

Content Item Descriptions 35

TID nnn3 Mammography CAD SR IOD Impression/Recommendation Body Template 36

Content Item Descriptions 36

TID nnn4 Mammography CAD SR IOD Individual Impression/Recommendation Template 37

Content Item Descriptions 37

TID nnn5 Mammography CAD SR IOD Composite Feature Template 38

TID nnn6 Mammography CAD SR IOD Composite Feature Body Template 39

Content Item Descriptions 40

TID nnn9 Mammography CAD SR IOD Single Image Finding Template 41

Content Item Descriptions 42

TID nnn10 Mammography CAD SR IOD Single Image Finding Generic Template 42

Content Item Descriptions 42

TID nnn11 Mammography CAD SR IOD Single Image Finding Breast Composition Template 43

Content Item Descriptions 43

TID nnn12 Mammography CAD SR IOD Single Image Finding Breast Geometry Template 43

Content Item Descriptions 43

TID nnn13.1 Mammography CAD SR IOD Single Image Finding Individual Calcification Template 44

TID nnn13.2 Mammography CAD SR IOD Single Image Finding Calcification Cluster Template 44

TID nnn14 Mammography CAD SR IOD Single Image Finding Density Template 45

TID nnn15 Mammography CAD SR IOD Single Image Finding Nipple Template 45

Content Item Descriptions 45

TID nnn16 Mammography CAD SR IOD Single Image Finding Non-Lesion Template 46

TID nnn17 Mammography CAD SR IOD Single Image Finding Selected Region Template 46

TID nnn18 Mammography CAD SR IOD Single Image Finding Image Quality Template 47

Content Item Descriptions 47

TID nnn19.1 Mammography CAD SR IOD Detections Performed Template 48

TID nnn19.2 Mammography CAD SR IOD Analyses Performed Template 48

TID nnn20 Mammography CAD SR IOD Detection Performed Template 49

Content Item Descriptions 49

TID nnn21 Mammography CAD SR IOD Analysis Performed Template 50

Content Item Descriptions 50

TID nnn21.5 Mammography CAD SR IOD Algorithm Identification Template 50

TID nnn22 Mammography CAD SR IOD Image Library Entry Template 51

Content Item Descriptions 51

TID nnn23.1 Mammography CAD SR IOD Linear Measurement Template 52

Content Item Descriptions 52

TID nnn23.2 Mammography CAD SR IOD Area Measurement Template 52

Content Item Descriptions 52

TID nnn23.3 Mammography CAD SR IOD Volume Measurement Template 53

Content Item Descriptions 53

TID nnn25 Mammography CAD SR IOD Geometry Template 53

ANNEX Y: Mammography CAD SR IOD Adoptive terminology and NOMENCLATURE 54

BI-RADS( Terminology and Nomenclature: 54

MQCM 1999 Terminology and Nomenclature 54

MQSA Terminology and Nomenclature 54

ANNEX Z: Mammography CAD SR IOD MICROGLOSSARY 55

CONTEXT GROUP 99115 – Overall Breast Composition 55

CONTEXT GROUP 99117 – Change Since Last Mammogram or Prior Surgery 55

CONTEXT GROUP 99118 – Characteristics of Shape 56

CONTEXT GROUP 99119 – Characteristics of Margin 56

CONTEXT GROUP 99120 – Density Modifier 56

CONTEXT GROUP 99121 – Calcification Types 56

CONTEXT GROUP 99122 – Calcification Distribution Modifier 57

CONTEXT GROUP 99126.1 – Single Image Finding 57

CONTEXT GROUP 99126.2 – Composite Feature 58

CONTEXT GROUP 99131 – Clockface Location 58

CONTEXT GROUP 99132 – Quadrant Location 59

CONTEXT GROUP 99133 – Side 59

CONTEXT GROUP 99134 – Depth 59

CONTEXT GROUP 99135 – Assessment 59

CONTEXT GROUP 99136 – Recommended Follow-up 60

CONTEXT GROUP 99143 – Pathology Codes 60

CONTEXT GROUP xxxx1 – Intended Use of CAD Output 63

CONTEXT GROUP xxxx2 – Composite Feature Relations 63

CONTEXT GROUP xxxx3 – Scope of Feature 64

CONTEXT GROUP xxxx4 – Quantitative Temporal Difference Type 64

CONTEXT GROUP xxxx4.1 – Qualitative Temporal Difference Type 64

CONTEXT GROUP xxxx5 – Nipple Status 64

CONTEXT GROUP xxxx6 – Non-Lesion Object Type 65

CONTEXT GROUP xxxx7 – Image Quality Finding 65

CONTEXT GROUP xxxx8 – Status of Results 67

CONTEXT GROUP xxxx9 – Types of CAD Analysis Performed 67

CONTEXT GROUP xxx10 – Types of Image Quality Assessment 68

CONTEXT GROUP xxx11 – Types of Quality Control Standard 68

CONTEXT GROUP xxx12 – Units of Follow-up Interval 68

CONTEXT GROUP xxx13 – Units of Linear Measurement 68

CONTEXT GROUP xxx14 – Units of Area Measurement 69

CONTEXT GROUP xxx15 – Units of Volume Measurement 69

CONTEXT GROUP xxx16 – Linear Measurements 69

CONTEXT GROUP xxx17 – Area Measurements 70

CONTEXT GROUP xxx18 – Volume Measurements 70

CONTEXT GROUP xxx19 – Units of 1D, 2D and 3D Measurement 70

CONTEXT GROUP xxx20 – CAD Processing Summary 70

Foreword

This supplement to the DICOM standard introduces the DICOM format for the results of computer-aided detection (CAD) of potential malignancies in mammograms. The supplement provides the means for encoding a CAD system’s mammographic analysis. This includes such basic information as:

• Lesion type, e.g., density, microcalcification cluster, architectural distortion

• Bounding regions of lesions, as given by a rectangle, ellipse or polyline

• Correlation between lesions detected in different views of a mammogram

The supplement also defines the DICOM format for advanced mammographic findings more commonly associated with computer-aided diagnosis (CADx). Examples of such findings include the morphology of lesions, descriptions of the breast architecture, image quality metrics and overall impressions of and recommendations for the mammogram. The use of CADx information is optional, so makers of systems that produce only CAD results can still use the format described herein.

This draft Supplement to the DICOM Standard was developed according to DICOM Committee Procedures. The DICOM Standard is developed in liaison with other Standards Organizations including HL7, CEN/TC 251 in Europe and MEDIS-DC, JAMI, and JIRA in Japan, with review by other organizations.

The DICOM Standard is structured as a multi-part document using the guidelines established in the following document:

- ISO/IEC Directives, 1989 Part 3 - Drafting and Presentation of International Standards.

This document is a Supplement to the DICOM Standard. It is an extension to PS 3.3, PS 3.4 and 3.6 of the published DICOM Standard which consists of the following parts:

PS 3.1 - Introduction and Overview

PS 3.2 - Conformance

PS 3.3 - Information Object Definitions

PS 3.4 - Service Class Specifications

PS 3.5 - Data Structures and Encoding

PS 3.6 - Data Dictionary

PS 3.7 - Message Exchange

PS 3.8 - Network Communication Support for Message Exchange

PS 3.9 - Point-to-Point Communication Support for Message Exchange

PS 3.10 - Media Storage and File Format

PS 3.11 - Media Storage Application Profiles

PS 3.12 - Media Formats and Physical Media

PS 3.13 - Print Management - Point-to-point Communication Support

PS 3.14 - Grayscale Standard Display Function

PS 3.15 - Security Profiles

These Parts are independent but related documents.

Scope and Field of Application

This supplement to the DICOM standard only defines how the results of a computer’s mammographic analysis (the CAD output) should be encoded. It does not define or describe inputs to the CAD system other than use of CAD output (e.g. prior year’s report) as input to subsequent temporal analyses; nor does it treat CAD output for studies other than mammograms. Note that the CAD input may be comprised of digitized or digitally acquired X-ray images, ultrasound or other germane mammographic images. Some of the information described is beyond that which current CAD systems can produce. However, the DICOM committee includes it because it is expected to become relevant during the lifetime of the supplement.

The CAD output is in the form of a DICOM Structured Report. The report can be used on its own, for example for displaying the detected lesions on a monitor or printer. It can be used within a larger Structured Report document, e.g., as part of a comprehensive mammogram screening report. It can even be used as input to a CAD system, for example to provide information on CAD detections in prior years’ mammograms. In all cases, the output is a Structured Report (SR), so readers should become familiar with Comprehensive SR IOD and corresponding SOP class. In addition, provision has been made to allow description of the CAD output using BI-RADS( terminology and nomenclature (see Annex Y, Z). International organizations are being encouraged to contribute additional terminology and nomenclature.

This document specifies the Mammography CAD SR IOD and the corresponding CAD Storage SOP class. Since this supplement proposes changes to existing parts of DICOM, the reader should have a working understanding of the Standard.

The Mammography CAD SR IOD object is designed to allow a sparsely populated content tree, depending on the capabilities of the CAD system producing this object. Since the content tree defined in this document can incorporate many of the same impressions a human observer would make (at least for a period of time) it is not a requirement that CAD systems be able to fully encode all elements in the content tree templates. Instead, CAD systems may populate optional elements as they see fit, to meet the requirements of the market; different CAD systems may populate the content tree differently.

The content tree sparseness does put more burden onto devices parsing and interpreting the content tree. Interoperability needs may force parsers to handle a broad array of sparsely populated trees.

OPEN ISSUES

1. What will the Supplement 53 Revision 18 “Observation Context, Quoted-Document” (currently TID 25) and “Quoted Document Root Context” (currently TID 59) and their subordinate templates finally look like? Are these sufficient for our needs?

2. International language translation: The CAD SR templates must have the flexibility to allow alternate language translations for Code Meaning. Determine how Supplement 53, Revision 18,TID 90 “Language Translation of code meaning field” should be incorporated into this document, and whether that is sufficient. Determine whether this affects the use of the CAD SR templates as Enumerated versus Defined.

3. Is “Rendering Intent” in conflict with the guideline that an SR SCP will faithfully render the full meaning of the document? See Supplement 23, Final Text, Part 4, Annex O.

4. How can a text-only Mammo report be generated from the same CAD SR that includes SCOORD if the SCOORD is in a “Required for Presentation” sub-tree?

5. Can a Mammography CAD SR SCP device, depending on its capability, opt (when available) to render certain locale information in textual form (e.g. “There is mass in the upper-outer quadrant” or “at the 11 o’clock position”) rather than “at location (569,2334)” when it is the most appropriate means of rendering the SR document to the clinician?

6. Review sections added to Part 4, Annex O, to explain the intended “Behavior of an SCU” and “Behavior of an SCP” for the Mammography CAD SR SOP Class. See also Supplement 23, Final Text, Annex O: Structured Reporting Storage SOP Classes.

7. All of the Concept Names and Context Groups defined in this Supplement must be assigned Code Values. The ACR is evaluating potential options for the encoding of the BI-RADSTM terminology.

8. Is there additional information we need to include about BI-RADSTM? Such as its use as defined terms vs. enumerated values, and allowing extensions for international use?

9. Review ACR legal statements

10. In TID nnn19.1 and TID nnn19.2, the Value Type of “Successful Detections”, “Failed Detections”, “Successful Analyses” and “Failed Analyses” was changed from CONTAINER to TEXT with a NULL value in order to maintain the rule from the Comprehensive SR IOD that “Content Items with a Value Type of CONTAINER shall only be the target of relationshis other than CONTAINS, if this relationship is conveyed by-reference”. See Supplement 23, Final Text, A.35.3.3.1.2.

11. If a content item has Required Type “U” and its target content item(s) have Required Type “M” then the target content item is only required if the source content item exists. The explanation of Required Type in Supplement 53 should clarify this.

Part 3, Annex A Addendum

Add the following to PS 3.3 Annex A

Update the Composite Module Table to include Mammography CAD SR IOD and Modules

|IODs |Mammography |

|Modules |CAD SR |

|Patient |M |

|Specimen |C |

|Identification | |

|General Study |M |

|Patient Study |U |

|SR Document |M |

|Series | |

|General |M |

|Equipment | |

|SR Document |M |

|General | |

|SR Document |M |

|Content | |

|SOP Common |M |

A.X Structured REPORT Document Information Object Definitions

A.X.1 CAD SR Information Object Definition

A.X.1.1 Mammography CAD SR Information Object Description

The Mammography CAD SR IOD is a constrained Comprehensive SR IOD. The content may include textual and a variety of coded information, numeric measurement values, references to the SOP Instances and spatial regions of interest within such SOP Instances. Relationships by-reference are enabled between Content Items.

A.X.1.2 Mammography CAD SR IOD Entity-Relationship Model

The E-R Model in Section A.1.2 of this Part applies to the Mammography CAD SR IOD. The Frame of Reference IE, and the IEs at the level of the Image IE in Section A.1.2 are not components of the Mammography CAD SR IOD. Table A.X.1-1 specifies the Modules of the Mammography CAD SR IOD.

A.X.1.3 Mammography CAD SR IOD Module Table

Table A.X.1-1 specifies the Modules of the Mammography CAD SR IOD.

Table A.X.1-1

MAMMOGRAPHY CAD SR IOD MODULES

|IE |Module |Reference |Usage |

|Patient |Patient |C.7.1.1 |M |

| |Specimen Identification |C.7.1.2 |C - Required if the Observation Subject is a Specimen |

|Study |General Study |C.7.2.1 |M |

| |Patient Study |C.7.2.2 |U |

|Series |SR Document Series |C.17.1 |M |

|Equipment |General Equipment |C.7.5.1 |M |

|Document |SR Document General |C.17.2 |M |

| |SR Document Content |C.17.3 |M |

| |SOP Common |C.12.1 |M |

A.X.1.3.1 Mammography CAD SR IOD Content Constraints

A.X.1.3.1.1 Template Identification

• The Mammography CAD SR Document Root content item shall be ETID nnn1.

• When another document is quoted, the Document Root Node shall use TID 59, Quoted Document Root Context, and its subordinate templates, as described in Supplement 53, DICOM Part 16: Templates and Context Groups, Revision 18 or later.

• When a content item sub-tree from a quoted document is included by-value, its observation context shall be defined byTID 25, Quoted-Document Observation Context, and its subordinate templates, as described in Supplement 53, DICOM Part 16:Templates and Context Groups, Revision 18 or later.

A.X.1.3.1.2 Value Type

Note: The Mammography CAD SR Document Root template and its subordinate templates make use of the following subset of the Value Type (0040,A040) as defined for the Comprehensive SR IOD:

TEXT

CODE

NUM

DATE

TIME

UIDREF

PNAME

SCOORD

COMPOSITE

IMAGE

CONTAINER

A.X.1.3.1.3 Relationship Constraints

Note: Table A.X.1-2 specifies the subset of the relationship constraints defined for the Comprehensive SR IOD.that are used by the Mammography CAD SR IOD.

Table A.X.1-2

RELATIONSHIP CONTENT CONSTRAINTS FOR MAMMOGRAPHY CAD SR IOD

|Source Value Type |Relationship Type (Enumerated |Target Value Type |

| |Values) | |

|CONTAINER |CONTAINS |CODE, NUM, SCOORD, IMAGE1, CONTAINER. |

|TEXT, CODE, NUM, CONTAINER |HAS OBS CONTEXT |TEXT, CODE, NUM, DATE, TIME, UIDREF, PNAME |

|IMAGE |HAS ACQ CONTEXT |TEXT, CODE, DATE, TIME. |

|TEXT, CODE |HAS PROPERTIES |TEXT, CODE, NUM, DATE, IMAGE1, SCOORD. |

|CODE, NUM |INFERRED FROM |CODE, NUM, SCOORD. |

|SCOORD |SELECTED FROM |IMAGE1 |

Part 3, Annex X Addendum

Add the following to PS 3.3

ANNEX X (INFORMATIVE)

X.1 Mammography CAD SR Content Tree Structure

The Mammography CAD SR IOD is a constrained instance of the Comprehensive SR IOD. The templates are defined in Part 16 Annex X.

a. All relationships defined in the Mammography CAD SR IOD templates are by-value, unless otherwise stated.

b. Content items referenced from another SR object instance, such as a prior Mammography CAD SR, are duplicated by-value in the new SR object instance, with appropriate quoted document observation context.

[pic]

Figure x.x.x.1: Top Levels of Mammography CAD SR Content Tree

The Document Root, Image Library, Summaries of Detections and Analyses, and Overall Impression/Recommendation sub-trees together form the content tree of the Mammography CAD SR IOD.

[pic]Figure x.x.x.2: Summary of Detections and Analyses Levels of

Mammography CAD SR Content Tree

The Summary of Detections and Summary of Analyses sub-trees are used to identify the algorithms used and the work done by the CAD device. These sub-trees illuminate why CAD processing may not produce results (no findings), which occurs in three categories:

a. All algorithms succeeded

b. Some algorithms succeeded, some failed, but no findings resulted

c. All algorithms failed

Note 1: If the tree contains no Individual Impression/Recommendation nodes and all attempted detections and analyses succeeded then the CAD device made no findings.

Note 2: Detections and Analyses that are not attempted are not listed in the Summary of Detections and Summary of Analyses trees.

Note 3: If the code value of the Summary of Detections or Summary of Analyses codes in TID nnn1 is “Not Attempted” then no detail of which algorithms were not attempted is provided.

[pic]Figure x.x.x.3: Individual Impression/Recommendation Levels of

Mammography CAD SR Content Tree

The shaded area in Figure x.x.x.3 demarcates information resulting from Detection, whereas the unshaded area is information resulting from Analysis. This distinction is used in determining whether to place algorithm identification information in the Summary of Detections or Summary of Analyses sub-trees.

The clustering of calcifications within a single image is considered to be a Detection process which results in a Single Image Finding. The spatial correlation of a calcification cluster in two views, resulting in a Composite Feature, is considered Analysis. The clustering of calcifications in a single image is the only circumstance in which a Single Image Finding can result from the combination of other Single Image Findings, which must be Individual Calcifications.

Once a Single Image Finding or Composite Feature has been instantiated, it may be referenced by any number of Composite Features higher in the tree.

X.2 Mammography CAD SR Observation Context Encoding

• Any content item in the Content tree that has been duplicated (i.e., quoted) from another SR object instance has a HAS OBS CONTEXT relationship to one or more content items that describe the context of the SR object instance from which it originated, as a quoted document. This mechanism may be used to combine reports (e.g., CAD 1, CAD 2, Human).

• Content items do not overwrite the Initial Observation Context defined outside the SR Document Content tree by other modules in the SR IOD (e.g., Patient, General Equipment, SR Document General modules).

• Context is not inherited in by reference relationships.

The Impression/Recommendation section of the SR Document Content tree of a Mammography CAD SR IOD may contain a mixture of current (direct) and prior (quoted) single image findings and composite features. The content items from current and prior contexts are target content items that have a by-value INFERRED FROM relationship to a Composite Feature content item. Content items quoted from a context other than the Initial Observation Context have a HAS OBS CONTEXT relationship to target content items that describe the context of the quoted document.

In the following example, Composite Feature and Single Image Finding 1 are current, and Single Image Finding 2 is quoted from a prior document.

X.3 Mammography CAD SR Examples

The following is a simple and non-comprehensive illustration of an encoding of the Mammography CAD SR IOD for Mammography computer aided detection results.

Example 1: Calcification and Mass Detection with No Findings

A CAD device processes a typical screening mammography case, i.e., there are four films and no cancer. CAD runs both density and calcification detection successfully and finds nothing. The mammograms resemble:

The content tree structure would resemble:

|Node |Code Meaning of Concept Name |Code Meaning of Value |TID |

|1 |Mammography CAD SR | |1 |

| | | | |

|1.1 |Image Library | |1 |

|1.1.1 |Image Used As Evidence |IMAGE 1 |22 |

|1.1.1.1 |Image Laterality |Right |22 |

|1.1.1.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.2 |Image Used As Evidence |IMAGE 2 |22 |

|1.1.2.1 |Image Laterality |Left |22 |

|1.1.2.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.3 |Image Used As Evidence |IMAGE 3 |22 |

|1.1.3.1 |Image Laterality |Right |22 |

|1.1.3.2 |Image View Code Sequence |Medio-lateral oblique |22 |

|1.1.4 |Image Used As Evidence |IMAGE 4 |22 |

|1.1.4.1 |Image Laterality |Left |22 |

|1.1.4.2 |Image View Code Sequence |Medio-lateral oblique |22 |

| | | | |

|1.2 |Summary of Detections |Succeeded |1 |

|1.2.1 |Successful Detections | |19.1 |

| | | | |

|1.2.1.1 |Detection Performed |Density |20 |

|1.2.1.1.1 |Algorithm ID |“Density Detector” |21.5 |

|1.2.1.1.2 |Algorithm Version |“V3.7” |21.5 |

|1.2.1.1.3 | |Reference to node 1.1.1 |20 |

|1.2.1.1.4 | |Reference to node 1.1.2 |20 |

|1.2.1.1.5 | |Reference to node 1.1.3 |20 |

|1.2.1.1.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.2.1.2 |Detection Performed |Individual Calcification |20 |

|1.2.1.2.1 |Algorithm ID |“Calc Detector” |21.5 |

|1.2.1.2.2 |Algorithm Version |“V2.4” |21.5 |

|1.2.1.2.3 | |Reference to node 1.1.1 |20 |

|1.2.1.2.4 | |Reference to node 1.1.2 |20 |

|1.2.1.2.5 | |Reference to node 1.1.3 |20 |

|1.2.1.2.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.3 |Summary of Analyses |Not Attempted |1 |

| | | | |

|1.4 |Overall Impression/Recommendation |All algorithms succeeded; without |2 |

| | |findings | |

Example 2: Calcification and Mass Detection with Findings

A CAD device processes a screening mammography case with four films and a mass in the left breast. CAD runs both density and calcification detection successfully. It finds two densities in the LCC, one density in the LMLO, a cluster of three calcifications in the RCC and a cluster of 20 calcifications in the RMLO. It performs two clustering algorithms. One identifies individual calcifications and then clusters them, and the second simply detects calcification clusters. It performs mass correlation and combines one of the LCC densities and the LMLO density into a mass; the other LCC density is flagged Not for Presentation, therefore not intended for display to the end-user. The mammograms resemble:

[pic]The content tree structure would resemble (preliminary diagram):

[pic]

|Node |Code Meaning of Concept Name |Code Meaning of Value |TID |

|1 |Mammography CAD SR | |1 |

| | | | |

|1.1 |Image Library | |1 |

|1.1.1 |Image Used As Evidence |IMAGE 1 |22 |

|1.1.1.1 |Image Laterality |Right |22 |

|1.1.1.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.1.3 |Study Date |19990101 |22 |

|1.1.2 |Image Used As Evidence |IMAGE 2 |22 |

|1.1.2.1 |Image Laterality |Left |22 |

|1.1.2.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.2.3 |Study Date |19990101 |22 |

|1.1.3 |Image Used As Evidence |IMAGE 3 |22 |

|1.1.3.1 |Image Laterality |Right |22 |

|1.1.3.2 |Image View Code Sequence |Medio-lateral oblique |22 |

|1.1.3.3 |Study Date |19990101 |22 |

|1.1.4 |Image Used As Evidence |IMAGE 4 |22 |

|1.1.4.1 |Image Laterality |Left |22 |

|1.1.4.2 |Image View Code Sequence |Medio-lateral oblique |22 |

|1.1.4.3 |Study Date |19990101 |22 |

| | | | |

|1.2 |Summary of Detections |Succeeded |1 |

|1.2.1 |Successful Detections | |19.1 |

| | | | |

|1.2.1.1 |Detection Performed |Density |20 |

|1.2.1.1.1 |Algorithm ID |“Density Detector” |21.5 |

|1.2.1.1.2 |Algorithm Version |“V3.7” |21.5 |

|1.2.1.1.3 | |Reference to node 1.1.1 |20 |

|1.2.1.1.4 | |Reference to node 1.1.2 |20 |

|1.2.1.1.5 | |Reference to node 1.1.3 |20 |

|1.2.1.1.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.2.1.2 |Detection Performed |Individual Calcification |20 |

|1.2.1.2.1 |Algorithm ID |“Calc Detector” |21.5 |

|1.2.1.2.2 |Algorithm Version |“V2.4” |21.5 |

|1.2.1.2.3 | |Reference to node 1.1.1 |20 |

|1.2.1.2.4 | |Reference to node 1.1.2 |20 |

|1.2.1.2.5 | |Reference to node 1.1.3 |20 |

|1.2.1.2.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.2.1.3 |Detection Performed |Calcification Cluster |20 |

|1.2.1.3.1 |Algorithm ID |“Calc Clustering” |21.5 |

|1.2.1.3.2 |Algorithm Version |“V2.4” |21.5 |

|1.2.1.3.3 | |Reference to node 1.1.1 |20 |

| | | | |

|1.2.1.4 |Detection Performed |Calcification Cluster |20 |

|1.2.1.4.1 |Algorithm ID |“Calc Cluster Detector” |21.5 |

|1.2.1.4.2 |Algorithm Version |“V2.4” |21.5 |

|1.2.1.4.3 | |Reference to node 1.1.1 |20 |

|1.2.1.4.4 | |Reference to node 1.1.2 |20 |

|1.2.1.4.5 | |Reference to node 1.1.3 |20 |

|1.2.1.4.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.3 |Summary of Analyses |Succeeded |1 |

|1.3.1 |Successful Analyses | |19.2 |

| | | | |

|1.3.1.1 |Analysis Performed |Mass Correlation |21 |

|1.3.1.1.1 |Algorithm ID |“Mass Maker” |21.5 |

|1.3.1.1.2 |Algorithm Version |“V1.9” |21.5 |

|1.3.1.1.3 | |Reference to node 1.1.2 |21 |

|1.3.1.1.4 | |Reference to node 1.1.4 |21 |

| | | | |

|1.4 |Overall Impression/Recommendation |All algorithms succeeded; with |2 |

| | |findings | |

|1.4.1 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.1.1 |Rendering Intent |Presentation Required |4 |

| | | | |

|1.4.1.2 |Composite Feature |Mass |5 |

|1.4.1.2.1 |Composite type |Target content items are related |6 |

| | |spatially | |

|1.4.1.2.2 |Scope of Feature |Feature was detected on multiple |6 |

| | |images | |

|1.4.1.2.3 |Rendering Intent |Presentation Required |6 |

| | | | |

|1.4.1.2.4 |Single Image Finding |Density |9 |

|1.4.1.2.4.1 |Rendering Intent |Presentation Required |9 |

|1.4.1.2.4.2 |Center |POINT |25 |

|1.4.1.2.4.2.1 | |Reference to node 1.1.2 |25 |

|1.4.1.2.4.3 |Outline |SCOORD |25 |

|1.4.1.2.4.3.1 | |Reference to node 1.1.2 |25 |

| | | | |

|1.4.1.2.5 |Single Image Finding |Density |9 |

|1.4.1.2.5.1 |Rendering Intent |Presentation Required |9 |

|1.4.1.2.5.2 |Area Measurement |Area of Defined Region |14 |

|1.4.1.2.5.2.1 |Measurement Name |Area of density |23.2 |

|1.4.1.2.5.2.2 |Area |2 cm2 |23.2 |

|1.4.1.2.5.2.3 |Area Outline |SCOORD |23.2 |

|1.4.1.2.5.2.3.1 | |Reference to node 1.1.4 |23.2 |

|1.4.1.2.5.3 |Center |POINT |25 |

|1.4.1.2.5.3.1 | |Reference to node 1.1.4 |25 |

|1.4.1.2.5.4 |Outline |SCOORD |25 |

|1.4.1.2.5.4.1 | |Reference to node 1.1.4 |25 |

| | | | |

|1.4.2 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.2.1 |Rendering Intent |Not for Presentation |4 |

|1.4.2.2 |Single Image Finding |Density |9 |

|1.4.2.2.1 |Rendering Intent |Not for Presentation |9 |

|1.4.2.2.2 |Center |POINT |25 |

|1.4.2.2.2.1 | |Reference to node 1.1.2 |25 |

|1.4.2.2.3 |Outline |SCOORD |25 |

|1.4.2.2.3.1 | |Reference to node 1.1.2 |25 |

| | | | |

|1.4.3 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.3.1 |Rendering Intent |Presentation Required |4 |

|1.4.3.2 |Single Image Finding |Calcification Cluster |9 |

|1.4.3.2.1 |Rendering Intent |Presentation Required |9 |

|1.4.3.2.2 |Number of Calcifications |20 |13.2 |

|1.4.3.2.3 |Center |POINT |25 |

|1.4.3.2.3.1 | |Reference to node 1.1.3 |25 |

|1.4.3.2.4 |Outline |SCOORD |25 |

|1.4.3.2.4.1 | |Reference to node 1.1.3 |25 |

| | | | |

|1.4.4 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.4.1 |Rendering Intent |Presentation Required |4 |

| | | | |

|1.4.4.2 |Single Image Finding |Calcification Cluster |9 |

|1.4.4.2.1 |Rendering Intent |Presentation Required |9 |

|1.4.4.2.2 |Number of Calcifications |3 |13.2 |

|1.4.4.2.3 |Center |POINT |25 |

|1.4.4.2.3.1 | |Reference to node 1.1.1 |25 |

|1.4.4.2.4 |Outline |SCOORD |25 |

|1.4.4.2.4.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.4.2.5 |Single Image Finding |Individual Calcification |9 |

|1.4.4.2.5.1 |Rendering Intent |Presentation Optional |9 |

|1.4.4.2.5.2 |Center |POINT |25 |

|1.4.4.2.5.2.1 | |Reference to node 1.1.1 |25 |

|1.4.4.2.5.3 |Outline |SCOORD |25 |

|1.4.4.2.5.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.4.2.6 |Single Image Finding |Individual Calcification |9 |

|1.4.4.2.6.1 |Rendering Intent |Presentation Optional |9 |

|1.4.4.2.6.2 |Center |POINT |25 |

|1.4.4.2.6.2.1 | |Reference to node 1.1.1 |25 |

|1.4.4.2.6.3 |Outline |SCOORD |25 |

|1.4.4.2.6.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.4.2.7 |Single Image Finding |Individual Calcification |9 |

|1.4.4.2.7.1 |Rendering Intent |Presentation Optional |9 |

|1.4.4.2.7.2 |Center |POINT |25 |

|1.4.4.2.7.2.1 | |Reference to node 1.1.1 |25 |

|1.4.4.2.7.3 |Outline |SCOORD |25 |

|1.4.4.2.7.3.1 | |Reference to node 1.1.1 |25 |

Example 3: Calcification and Mass Detection, Temporal Differencing with Findings

The patient in Example 2 returns for another mammogram. A more comprehensive CAD (CADx) device processes the current mammogram. The prior CAD report (from Example 2) is referenced and sections of the content tree from the prior CAD report are incorporated. In the current mammogram the number of calcifications in the RCC has increased, and the size of the mass in the left breast has increased from 2 to 4 cm2.

[pic]Bolded entries (xxx) in the following table denote references to or by-value inclusion of quoted content tree items from a prior Mammography CAD SR instance (see example 2).

|Node |Code Meaning of Concept Name |Code Meaning of Value |TID |

|1 |Mammography CAD SR | |1 |

|1.x |Observation Context of Quoted Document Root | |59 |

| | | |§531 |

| | | | |

|1.1 |Image Library | |1 |

|1.1.1 |Image Used As Evidence |IMAGE 1 |22 |

|1.1.1.1 |Image Laterality |Right |22 |

|1.1.1.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.1.3 |Study Date |20000101 |22 |

|1.1.2 |Image Used As Evidence |IMAGE 2 |22 |

|1.1.2.1 |Image Laterality |Left |22 |

|1.1.2.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.2.3 |Study Date |20000101 |22 |

|1.1.3 |Image Used As Evidence |IMAGE 3 |22 |

|1.1.3.1 |Image Laterality |Right |22 |

|1.1.3.2 |Image View Code Sequence |Medio-lateral oblique |22 |

|1.1.3.3 |Study Date |20000101 |22 |

|1.1.4 |Image Used As Evidence |IMAGE 4 |22 |

|1.1.4.1 |Image Laterality |Left |22 |

|1.1.4.2 |Image View Code Sequence |Medio-lateral oblique |22 |

|1.1.4.3 |Study Date |20000101 |22 |

|1.1.5 |Image Used As Evidence |IMAGE 5 |22 |

|1.1.5.1 |Image Laterality |Right |22 |

|1.1.5.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.5.3 |Study Date |19990101 |22 |

|1.1.6 |Image Used As Evidence |IMAGE 6 |22 |

|1.1.6.1 |Image Laterality |Left |22 |

|1.1.6.2 |Image View Code Sequence |Cranio-caudal |22 |

|1.1.6.3 |Study Date |19990101 |22 |

|1.1.7 |Image Used As Evidence |IMAGE 7 |22 |

|1.1.7.1 |Image Laterality |Right |22 |

|1.1.7.2 |Image View Code Sequence |Medio-lateral oblique |22 |

|1.1.7.3 |Study Date |19990101 |22 |

|1.1.8 |Image Used As Evidence |IMAGE 8 |22 |

|1.1.8.1 |Image Laterality |Left |22 |

|1.1.8.2 |Image View Code Sequence |Medio-lateral oblique |22 |

|1.1.8.3 |Study Date |19990101 |22 |

| | | | |

|1.2 |Summary of Detections |Succeeded |1 |

|1.2.1 |Successful Detections | |19.1 |

| | | | |

|1.2.1.1 |Detection Performed |Density |20 |

|1.2.1.1.1 |Algorithm ID |“Density Detector” |21.5 |

|1.2.1.1.2 |Algorithm Version |“V3.7” |21.5 |

|1.2.1.1.3 | |Reference to node 1.1.1 |20 |

|1.2.1.1.4 | |Reference to node 1.1.2 |20 |

|1.2.1.1.5 | |Reference to node 1.1.3 |20 |

|1.2.1.1.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.2.1.2 |Detection Performed |Individual Calcification |20 |

|1.2.1.2.1 |Algorithm ID |“Calc Detector” |21.5 |

|1.2.1.2.2 |Algorithm Version |“V2.4” |21.5 |

|1.2.1.2.3 | |Reference to node 1.1.1 |20 |

|1.2.1.2.4 | |Reference to node 1.1.2 |20 |

|1.2.1.2.5 | |Reference to node 1.1.3 |20 |

|1.2.1.2.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.2.1.3 |Detection Performed |Calcification Cluster |20 |

|1.2.1.3.1 |Algorithm ID |“Calc Clustering” |21.5 |

|1.2.1.3.2 |Algorithm Version |“V2.4” |21.5 |

|1.2.1.3.3 | |Reference to node 1.1.1 |20 |

| | | | |

|1.2.1.4 |Detection Performed |Calcification Cluster |20 |

|1.2.1.4.1 |Algorithm ID |“Calc Cluster Detector” |21.5 |

|1.2.1.4.2 |Algorithm Version |“V2.4” |21.5 |

|1.2.1.4.3 | |Reference to node 1.1.1 |20 |

|1.2.1.4.4 | |Reference to node 1.1.2 |20 |

|1.2.1.4.5 | |Reference to node 1.1.3 |20 |

|1.2.1.4.6 | |Reference to node 1.1.4 |20 |

| | | | |

|1.3 |Summary of Analyses |Succeeded |1 |

|1.3.1 |Successful Analyses | |19.2 |

| | | | |

|1.3.1.1 |Analysis Performed |Mass Correlation |21 |

|1.3.1.1.1 |Algorithm ID |“Mass Maker” |21.5 |

|1.3.1.1.2 |Algorithm Version |“V1.9” |21.5 |

|1.3.1.1.3 | |Reference to node 1.1.2 |21 |

|1.3.1.1.4 | |Reference to node 1.1.4 |21 |

| | | | |

|1.4 |Overall Impression/Recommendation |All algorithms succeeded; with |2 |

| | |findings | |

|1.4.1 |Assessment Category |4 – Suspicious abnormality, biopsy |3 |

| | |should be considered | |

|1.4.2 |Recommend Follow-up Interval |0 days |3 |

| | | | |

|1.4.3 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.3.1 |Rendering Intent |Presentation Required |4 |

|1.4.3.2 |Differential Diagnosis/Impression |Increase in size |3 |

|1.4.3.3 |Impression description |“Worrisome increase in size” |3 |

|1.4.3.4 |Certainty of impression |84% |3 |

|1.4.3.5 |Recommended Follow-up |Needle localization and biopsy (L) |3 |

| | | | |

|1.4.3.6 |Composite Feature |Mass |5 |

|1.4.3.6.1 |Composite type |Target content items are related |6 |

| | |temporally | |

|1.4.3.6.2 |Scope of Feature |Feature was detected on multiple |6 |

| | |images | |

|1.4.3.6.3 |Rendering Intent |Presentation Required |6 |

|1.4.3.6.4 |Certainty of Feature |91% |6 |

|1.4.3.6.5 |Probability of Cancer |84% |6 |

|1.4.3.6.6 |Pathology |Lobular carcinoma in situ |6 |

|1.4.3.6.7 |Quantitative Difference |Size |6 |

|1.4.3.6.7.1 |Difference value A-B |2 cm2 |6 |

|1.4.3.6.7.2 | |Reference to node 1.4.3.8.6.1.2 |6 |

|1.4.3.6.7.3 | |Reference to node 1.4.3.7.5.2.2 |6 |

|1.4.3.6.8 |Lesion Density |High density |6 |

|1.4.3.6.9 |Shape |Lobular |6 |

|1.4.3.6.10 |Margins |Microlobulated |6 |

| | | | |

|1.4.3.7 |Composite Feature |Mass |5 |

|1.4.3.7.1 |Composite type |Target content items are related |6 |

| | |spatially | |

|1.4.3.7.2 |Scope of Feature |Feature was detected on multiple |6 |

| | |images | |

|1.4.3.7.3 |Rendering Intent |Presentation Required |6 |

| | | | |

|1.4.3.7.4 |Single Image Finding |Density |9 |

|1.4.3.7.4.1 |Rendering Intent |Presentation Required |9 |

|1.4.3.7.4.2 |Center |POINT |25 |

|1.4.3.7.4.2.1 | |Reference to node 1.1.2 |25 |

|1.4.3.7.4.3 |Outline |SCOORD |25 |

|1.4.3.7.4.3.1 | |Reference to node 1.1.2 |25 |

| | | | |

|1.4.3.7.5 |Single Image Finding |Density |9 |

|1.4.3.7.5.1 |Rendering Intent |Presentation Required |9 |

|1.4.3.7.5.2 |Area Measurement |Area of Defined Region |14 |

|1.4.3.7.5.2.1 |Measurement Name |Area of density |23.2 |

|1.4.3.7.5.2.2 |Area |4 cm2 |23.2 |

|1.4.3.7.5.2.3 |Area Outline |SCOORD |23.2 |

|1.4.3.7.5.2.3.1 | |Reference to node 1.1.4 |23.2 |

|1.4.3.7.5.3 |Center |POINT |25 |

|1.4.3.7.5.3.1 | |Reference to node 1.1.4 |25 |

|1.4.3.7.5.4 |Outline |SCOORD |25 |

|1.4.3.7.5.4.1 | |Reference to node 1.1.4 |25 |

| | | | |

|1.4.3.8 |Composite Feature |Mass |5 |

|1.4.3.8.1 |Composite type |Target content items are related |6 |

| | |spatially | |

|1.4.3.8.2 |Scope of Feature |Feature was detected on multiple |6 |

| | |images | |

|1.4.3.8.3 |Rendering Intent |Presentation Required |6 |

|1.4.3.8.4 |Observation Context of Quoted Document | |25 |

| | | |§531 |

| | | | |

|1.4.3.8.5 |Single Image Finding |Density |9 |

|1.4.3.8.5.1 |Rendering Intent |Presentation Required |9 |

|1.4.3.8.5.2 |Center |POINT |25 |

|1.4.3.8.5.2.1 | |Reference to node 1.1.6 |25 |

|1.4.3.8.5.3 |Outline |SCOORD |25 |

|1.4.3.8.5.3.1 | |Reference to node 1.1.6 |25 |

| | | | |

|1.4.3.8.6 |Single Image Finding |Density |9 |

|1.4.3.8.6.1 |Rendering Intent |Presentation Required |9 |

|1.4.3.8.6.1 |Area Measurement |Area of Defined Region |14 |

|1.4.3.8.6.1.1 |Measurement Name |Area of density |23.2 |

|1.4.3.8.6.1.2 |Area |2 cm2 |23.2 |

|1.4.3.8.6.1.3 |Area Outline |SCOORD |23.2 |

|1.4.3.8.6.1.3.1 | |Reference to node 1.1.8 |23.2 |

|1.4.3.8.6.2 |Center |POINT |25 |

|1.4.3.8.6.2.1 | |Reference to node 1.1.8 |25 |

|1.4.3.8.6.3 |Outline |SCOORD |25 |

|1.4.3.8.6.3.1 | |Reference to node 1.1.8 |25 |

| | | | |

|1.4.4 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.4.1 |Rendering Intent |Not for Presentation |4 |

|1.4.4.2 |Single Image Finding |Density |9 |

|1.4.4.2.1 |Rendering Intent |Not for Presentation |9 |

|1.4.4.2.2 |Center |POINT |25 |

|1.4.4.2.2.1 | |Reference to node 1.1.2 |25 |

|1.4.4.2.3 |Outline |SCOORD |25 |

|1.4.4.2.3.1 | |Reference to node 1.1.2 |25 |

| | | | |

|1.4.5 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.5.1 |Rendering Intent |Presentation Required |4 |

|1.4.5.2 |Single Image Finding |Calcification Cluster |9 |

|1.4.5.2.1 |Rendering Intent |Presentation Required |9 |

|1.4.5.2.2 |Number of Calcifications |20 |13.2 |

|1.4.5.2.3 |Center |POINT |25 |

|1.4.5.2.3.1 | |Reference to node 1.1.3 |25 |

|1.4.5.2.4 |Outline |SCOORD |25 |

|1.4.5.2.4.1 | |Reference to node 1.1.3 |25 |

| | | | |

|1.4.6 |Individual Impression/Recommendation |INDIVIDUAL |4 |

|1.4.6.1 |Rendering Intent |Presentation Required |4 |

|1.4.6.2 |Differential Diagnosis/Impression |Increase in number of calcifications |3 |

|1.4.6.3 |Impression description |“Calcification cluster has increased |3 |

| | |in size” | |

|1.4.6.4 |Certainty of impression |100% |3 |

|1.4.6.5 |Recommended Follow-up |Magnification views (M) |3 |

| | | | |

|1.4.7.2 |Composite Feature |Calcification Cluster |5 |

|1.4.7.2.1 |Composite type |Target content items are related |6 |

| | |temporally | |

|1.4.7.2.2 |Scope of Feature |Feature was detected on multiple |6 |

| | |images | |

|1.4.7.2.3 |Rendering Intent |Presentation Required |6 |

|1.4.7.2.4 |Certainty of Feature |99% |6 |

|1.4.7.2.5 |Probability of Cancer |54% |6 |

|1.4.7.2.6 |Pathology |Ductal carcinoma in situ |6 |

|1.4.7.2.7 |Quantitative Difference |Number of Calcifications |6 |

|1.4.7.2.7.1 |Difference value A-B |3 |6 |

|1.4.7.2.7.2 | |Reference to node 1.4.7.2.10.2 |6 |

|1.4.7.2.7.3 | |Reference to node 1.4.7.2.11.2 |6 |

|1.4.7.2.8 |Calcification type |Fine, linear, branching (casting) |6 |

|1.4.7.2.9 |Calcification distribution |Grouped or clustered |6 |

| | | | |

|1.4.7.2.10 |Single Image Finding |Calcification Cluster |9 |

|1.4.7.2.10.1 |Rendering Intent |Presentation Required |9 |

|1.4.7.2.10.2 |Number of Calcifications |6 |13.2 |

|1.4.7.2.10.3 |Center |POINT |25 |

|1.4.7.2.10.3.1 | |Reference to node 1.1.1 |25 |

|1.4.7.2.10.4 |Outline |SCOORD |25 |

|1.4.7.2.10.4.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.7.2.10.5 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.10.5.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.10.5.2 |Center |POINT |25 |

|1.4.7.2.10.5.2.1 | |Reference to node 1.1.1 |25 |

|1.4.7.2.10.5.3 |Outline |SCOORD |25 |

|1.4.7.2.10.5.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.7.2.10.6 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.10.6.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.10.6.2 |Center |POINT |25 |

|1.4.7.2.10.6.2.1 | |Reference to node 1.1.1 |25 |

|1.4.7.2.10.6.3 |Outline |SCOORD |25 |

|1.4.7.2.10.6.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.7.2.10.7 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.10.7.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.10.7.2 |Center |POINT |25 |

|1.4.7.2.10.7.2.1 | |Reference to node 1.1.1 |25 |

|1.4.7.2.10.7.3 |Outline |SCOORD |25 |

|1.4.7.2.10.7.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.7.2.10.8 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.10.8.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.10.8.2 |Center |POINT |25 |

|1.4.7.2.10.8.2.1 | |Reference to node 1.1.1 |25 |

|1.4.7.2.10.8.3 |Outline |SCOORD |25 |

|1.4.7.2.10.8.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.7.2.10.9 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.10.9.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.10.9.2 |Center |POINT |25 |

|1.4.7.2.10.9.2.1 | |Reference to node 1.1.1 |25 |

|1.4.7.2.10.9.3 |Outline |SCOORD |25 |

|1.4.7.2.10.9.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.7.2.10.10 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.10.10.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.10.10.2 |Center |POINT |25 |

|1.4.7.2.10.10.2.1 | |Reference to node 1.1.1 |25 |

|1.4.7.2.10.10.3 |Outline |SCOORD |25 |

|1.4.7.2.10.10.3.1 | |Reference to node 1.1.1 |25 |

| | | | |

|1.4.7.2.11 |Single Image Finding |Calcification Cluster |9 |

|1.4.7.2.11.1 |Rendering Intent |Presentation Required |9 |

|1.4.7.2.11.2 |Number of Calcifications |3 |13.2 |

|1.4.7.2.11.3 |Observation Context of Quoted Document | |25 |

| | | |§531 |

|1.4.7.2.11.4 |Center |POINT |25 |

|1.4.7.2.11.4.1 | |Reference to node 1.1.5 |25 |

|1.4.7.2.11.5 |Outline |SCOORD |25 |

|1.4.7.2.11.5.1 | |Reference to node 1.1.5 |25 |

| | | | |

|1.4.7.2.11.6 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.11.6.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.11.6.2 |Center |POINT |25 |

|1.4.7.2.11.6.2.1 | |Reference to node 1.1.5 |25 |

|1.4.7.2.11.6.3 |Outline |SCOORD |25 |

|1.4.7.2.11.6.3.1 | |Reference to node 1.1.5 |25 |

| | | | |

|1.4.7.2.11.7 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.11.7.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.11.7.2 |Center |POINT |25 |

|1.4.7.2.11.7.2.1 | |Reference to node 1.1.5 |25 |

|1.4.7.2.11.7.3 |Outline |SCOORD |25 |

|1.4.7.2.11.7.3.1 | |Reference to node 1.1.5 |25 |

| | | | |

|1.4.7.2.11.8 |Single Image Finding |Individual Calcification |9 |

|1.4.7.2.11.8.1 |Rendering Intent |Presentation Optional |9 |

|1.4.7.2.11.8.2 |Center |POINT |25 |

|1.4.7.2.11.8.2.1 | |Reference to node 1.1.5 |25 |

|1.4.7.2.11.8.3 |Outline |SCOORD |25 |

|1.4.7.2.11.8.3.1 | |Reference to node 1.1.5 |25 |

1 Refers to a Supplement 53 Revision 18 template ID; subject to change prior to Supplement 53 approval.

Part 4 Addendum

Update Annex B and I SOP Class tables

Add Mammography CAD SR Storage SOP Class to Table B.5-1

B.5 Standard SOP Classes

|SOP Class Name |SOP Class UID |IOD (See PS 3.3) |

|Mammography CAD SR |1.2.840.10008.5.1.4.1.1.88.34 |Mammography CAD SR IOD |

B.5.1.5 Structured Reporting Storage SOP Classes

For SOP classes Basic Text SR, Enhanced SR, Comprehensive SR and Mammography CAD SR sSee Annex O.

Add Mammography CAD SR Storage Media Storage SOP Classes to Table I.4-1

I.4 MEDIA STANDARD STORAGE SOP Classes

|SOP Class Name |SOP Class UID |IOD (See PS 3.3) |

|Mammography CAD SR |1.2.840.10008.5.1.4.1.1.88.34 |Mammography CAD SR IOD |

Update Annex O

O.2.x Mammography CAD SR SOP Class

The Mammography CAD SR object contains data not only for presentation to the clinician, but also data solely for use in subsequent CAD analyses.

The SCU provides rendering guidelines via “Rendering Intent” content items associated with “Individual Impression/Recommendation”, “Composite Feature” and “Single Image Finding” content items. The full meaning of the SR is provided if the tree is rendered down to the first instance of “Not for Presentation” or “Presentation Optional” for each branch of the tree. Use of the SCU’s Conformance Statement is recommended if further enhancement of the meaning of the SR can be accomplished by rendering some or all of the data marked “Presentation Optional”. Data marked “Not for Presentation” should not be rendered by the SCP ― it is embedded in the SR content tree as input to subsequent Mammography CAD analysis work steps.

SCP devices creating human readable text output shall (when available) render content in the most human readable form. For instance, if quadrant and clock-face information is not available as an alternate for SCOORD data, then the SCOORD feature location shall be rendered either in (X,Y) pixel coordinates or (X,Y) in distance units.

O.4.1.x Mammography CAD SR SOP Class

The following shall be documented in the Conformance Statement of any implementation claiming conformance to the Mammography CAD SR SOP Class as an SCU:

• Which algorithms the device is capable of performing:

• From detections listed in CID 99126.1

• From analyses listed in CID xxxx9

• Which optional content items are supported

• Recommendations to SCPs regarding the rendering of “Presentation Optional” content items

• Recommendations to SCPs regarding how to render to the clinician the “Presentation Required” SCOORD content items

O.4.2.x Mammography CAD SR SOP Class

The following shall be documented in the Conformance Statement of any implementation claiming conformance to the Mammography CAD SR SOP Class as an SCP:

• In what manner the SCP renders the SCOORD content items

• Whether the SCP will render “Presentation Optional” content items

Part 6 Addendum

Annex A (Normative): Registry of DICOM Unique Identifiers (UID)

Add the following UIDs to Part 6 Annex A:

|UID Value |UID NAME |UID TYPE |Part |

|1.2.840.10008.5.1.4.1.1.88.34 |Mammography CAD SR |SOP Class |3.4 |

Part 16 Addendum

Annex X: MAMMOGRAPHY CAD SR IOD TEMPLATES

Add the following Templates to Part 16 Annex X:

The templates that comprise the Mammography CAD SR IOD are interconnected as follows:

[pic]

TID nnn1 Mammography CAD SR IOD Document Root Template

This template forms the top of a content tree that allows a CAD device to describe the results of detection and analysis of Mammographic evidence. This template, together with its subordinate templates, describes both the results for presentation to radiologists and partial product results for consumption by CAD devices in subsequent CAD reports.

This template defines a Container which contains an Image Library, summaries of detection and analysis algorithms performed, and the CAD results. The Image Library contains the Image SOP Class and Instance UIDs, and selected attributes for each image referenced in either the algorithm summaries or CAD results.

The Summary of Detections and Summary of Analyses Containers gather lists of algorithms attempted, grouped by success/failure status. Algorithms not attempted are not mentioned in these Containers. This information forms the basis for understanding why a CAD report may produce no (or fewer than anticipated) results. CAD results are constructed bottom-up, starting from Single Image Findings (see Template nnn9), associated as Composite Features (see Template nnn5), and from which Individual and Overall Impressions are formed.

The tree headed by this template is illustrated in Figure x.x.x.1 of Part 3, Annex X (Mammography CAD SR Content Tree Structure).

TID nnn1

MAMMOGRAPHY CAD SR IOD DOCUMENT ROOT

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CONTAINER |(cv, csd, “Mammography CAD SR”) |1 |M | | |

|2 |> |HAS OBS |INCLUDE |ETID (TID nnn59) |1-n |MC |Required if another document is | |

| | |CONTEXT | |“Quoted Document Root Context” | | |quoted within this document. | |

|3 |> |CONTAINS |CONTAINER |(cv, csd, “Image Library”) |1 |M | | |

|4 |>> |CONTAINS |INCLUDE |ETID (TID nnn22) |1-n |M | | |

| | | | |“Image Library Entry” | | | | |

|5 |> |CONTAINS |CODE |(cv, csd, “Summary of |1 |M | |ECID (CID xxxx8) “Status of |

| | | | |Detections”) | | | |Results” |

|6 |>> |INFERRED FROM|INCLUDE |ETID (TID nnn19.1) |1 |MC |Shall be present only if the | |

| | | | |“Detections Performed” | | |“Summary of Detections” is not | |

| | | | | | | |“Not Attempted” | |

|7 |> |CONTAINS |CODE |(cv, csd, “Summary of Analyses”)|1 |M | |ECID (CID xxxx8) “Status of |

| | | | | | | | |Results” |

|8 |>> |INFERRED FROM|INCLUDE |ETID (TID nnn19.2) |1 |MC |Shall be present only if the | |

| | | | |“Analyses Performed” | | |“Summary of Analyses” is not “Not| |

| | | | | | | |Attempted” | |

|9 |> |CONTAINS |INCLUDE |ETID (TID nnn2) |1 |M | | |

| | | | |“Overall Impression / | | | | |

| | | | |Recommendation” | | | | |

Content Item Descriptions

|Image Library |The “Image Library” section of the Content Tree (TID nnn1, row 3) shall include all Image SOP Instances |

| |from the Current Requested Procedure Evidence Sequence (0040,A375) attribute of the SR Document General |

| |module. If a portion of another instance of a Mammography CAD SR IOD is quoted in the “Overall |

| |Impression/ Recommendation” section of the Content Tree, the “Image Library” shall also include the Image|

| |SOP Instances from the Pertinent Other Evidence Sequence (0040,A385) attribute of the SR Document General|

| |module that are referenced by the quoted items. |

|Detections Performed |The “Detections Performed” and “Analyses Performed” sections of the Content Tree (TID nnn1, rows 6 and 8)|

| |together shall reference all Image SOP Instances included in the Current Requested Procedure Evidence |

| |Sequence (0040,A375) attribute of the SR Document General module. |

|Analyses Performed | |

TID nnn2 Mammography CAD SR IOD Overall Impression/Recommendation Template

This template forms the top of the CAD results sub-tree. The contents of this template describe the overall impression the CAD device had for the mammographic evidence presented and any recommendations that the CAD device made. The details of the impression and recommendation are expressed in the Impression/Recommendation Body (see TID nnn3). The data from which the details are inferred are expressed in the Individual Impression/Recommendations (see TID nnn4), of which there may be several.

TID nnn2

MAMMOGRAPHY CAD SR IOD OVERALL IMPRESSION/RECOMMENDATION

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Overall Impression/ |1 |M | |ECID (CID xxx20) “CAD |

| | | | |Recommendation”) | | | |Processing Summary” |

|2 |> |HAS PROP |INCLUDE |ETID (TID nnn3) |1 |U | | |

| | | | |“Impression/Recommendation Body”| | | | |

|3 |> |INFERRED FROM|INCLUDE |ETID (TID nnn4) |1-n |MC |Shall be present if 1 or more | |

| | | | |“Individual | | |single image finding was detected| |

| | | | |Impression/Recommendation” | | | | |

Content Item Descriptions

|Overall Impression/ Recommendation |This code value is used to express if and why the Overall Impression/Recommendation sub-tree is empty. |

| |The Summary of Detections and Summary of Analyses sub-trees of the Document Root node contain detail |

| |about which (if any) algorithms succeeded or failed. |

TID nnn3 Mammography CAD SR IOD Impression/Recommendation Body Template

The details of an impression and recommendation are expressed in this template. It is applied to both Overall Impression/Recommendation (TID nnn2) and Individual Impression/Recommendation (TID nnn4).

TID nnn3

MAMMOGRAPHY CAD SR IOD IMPRESSION/RECOMMENDATION BODY

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Assessment Category”)|1 |MC |At least one of elements 1, 2, 3,|ECID (CID 99135) “Assessment” |

| | | | | | | |4, 5, 6 shall be present. | |

|2 | | |CODE |(cv, csd, “Differential |1-n |MC |At least one of elements 1, 2, 3,|DCID (CID 99117) “Change Since |

| | | | |Diagnosis/ Impression”) | | |4, 5, 6 shall be present. |Last Mammogram or Prior Surgery”|

|3 | | |TEXT |(cv, csd, “Impression |1 |MC |At least one of elements 1, 2, 3,| |

| | | | |description”) | | |4, 5, 6 shall be present. | |

|4 | | |CODE |(cv, csd, “Recommended |1-n |MC |At least one of elements 1, 2, 3,|DCID (CID 99136) “Recommended |

| | | | |Follow-up”) | | |4, 5, 6 shall be present. |Follow-up” |

|5 | | |NUM |(cv, csd, “Recommended Follow-up|1 |MC |At least one of elements 1, 2, 3,|UNITS = DCID (CID xxx12) “Units |

| | | | |Interval”) | | |4, 5, 6 shall be present. May be|of Follow-up Interval”; Values =|

| | | | | | | |present only if “Recommended |Integer ( 0 |

| | | | | | | |Follow-up Date” is not present. | |

|6 | | |DATE |(cv, csd, “Recommended Follow-up|1 |MC |At least one of elements 1, 2, 3,|Shall be later than date of exam|

| | | | |Date”) | | |4, 5, 6 shall be present. May be| |

| | | | | | | |present only if “Recommended | |

| | | | | | | |Follow-up Interval” is not | |

| | | | | | | |present. | |

|7 | | |NUM |(cv, csd, “Certainty of |1 |UC |May be present only if |UNITS = (cv, csd, “Percent”) |

| | | | |impression”) | | |“Assessment Category”, |Values = 0 – 100 |

| | | | | | | |“Differential | |

| | | | | | | |Diagnosis/Impression” or | |

| | | | | | | |“Impression Description” is | |

| | | | | | | |present. | |

Content Item Descriptions

|Certainty of Impression |The certainty that the device populating the Mammography CAD SR report places on this impression, where 0|

| |equals no certainty and 100 equals assurance. |

TID nnn4 Mammography CAD SR IOD Individual Impression/Recommendation Template

This template collects an individual impression the CAD device had for a lesion, non-lesion object, or correlation of related objects. The details of the impression and recommendation are expressed in the Impression/Recommendation Body (see TID nnn3). The data from which the details are inferred are expressed in the Composite Features (see TID nnn5) and/or Single Image Findings (see TID nnn9) of which there may be several.

The sub-tree headed by this template is illustrated in Figure x.x.x.3 of Part 3, Annex X (Mammography CAD SR Content Tree Structure).

TID nnn4

MAMMOGRAPHY CAD SR IOD INDIVIDUAL IMPRESSION/RECOMMENDATION

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Individual |1 |M | |EV (cv, csd, “INDIVIDUAL”) |

| | | | |Impression/ Recommendation”) | | | | |

|2 |> |HAS PROP |CODE |(cv, csd, “Rendering Intent”) |1 |M | |ECID (CID xxxx1) “Intended Use |

| | | | | | | | |of CAD Output” |

|3 |> |HAS PROP |INCLUDE |ETID (TID nnn3) |1 |U | | |

| | | | |“Impression / Recommendation | | | | |

| | | | |Body” | | | | |

|4 |> |INFERRED FROM|INCLUDE |ETID (TID nnn5) |1-n |U | | |

| | | | |“Composite Feature” | | | | |

|5 |> |INFERRED FROM|INCLUDE |ETID (TID nnn9) |1-n |U | | |

| | | | |“Single Image Finding” | | | | |

Content Item Descriptions

|Rendering Intent |This content item constrains the SCP receiving the Mammography CAD SR IOD in its use of the contents of |

| |this template and its target content items. CAD devices may opt to use data marked “Not for |

| |Presentation” or “Presentation Optional” as input to subsequent CAD processing steps. |

TID nnn5 Mammography CAD SR IOD Composite Feature Template

This template collects a composite feature for a lesion, non-lesion object, or correlation of related objects. The details of the composition are expressed in the Composite Feature Body (see TID nnn6). The data from which the details are inferred are expressed in the Composite Features (see TID nnn5) and/or Single Image Findings (see TID nnn9) of which there may be several.

A Composite Feature shall be INFERRED FROM any combination of two or more Composite Features or Single Image Findings or mixture thereof.

TID nnn5

MAMMOGRAPHY CAD SR IOD COMPOSITE FEATURE

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Composite Feature”) |1 |M | |ECID (CID 99126.2) “Composite |

| | | | | | | | |Feature” |

|2 |> |HAS PROP |INCLUDE |ETID (TID nnn6) |1 |M | | |

| | | | |“Composite Feature Body” | | | | |

|3 |> |INFERRED FROM|INCLUDE |ETID (TID nnn5) |1-n |U | | |

| | | | |“Composite Feature” | | | | |

|4 |> |INFERRED FROM|INCLUDE |ETID (TID nnn9) |1-n |U | | |

| | | | |“Single Image Finding” | | | | |

|5 |> |HAS OBS |INCLUDE |ETID (TID 25) |1 |MC |Shall be present only if this | |

| | |CONTEXT | | | | |feature is quoted from a | |

| | | | | | | |different report. | |

TID nnn6 Mammography CAD SR IOD Composite Feature Body Template

The details of a composite feature are expressed in this template. It is applied to Composite Feature (TID nnn5).

TID nnn6

MAMMOGRAPHY CAD SR IOD COMPOSITE FEATURE BODY

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Composite type”) |1 |M | |ECID (CID xxxx2) “Composite |

| | | | | | | | |Feature Relations “. The value |

| | | | | | | | |shall be “contra-lateral” if the|

| | | | | | | | |parent content item has code |

| | | | | | | | |value “Focal Asymmetric Density”|

| | | | | | | | |or “Asymmetric Breast Tissue”. |

|2 | | |CODE |(cv, csd, “Scope of Feature”) |1 |M | |ECID (CID xxxx3) “Scope of |

| | | | | | | | |Feature” |

|3 | | |CODE |(cv, csd, “Rendering Intent”) |1 |M | |ECID (CID xxxx1) “Intended Use |

| | | | | | | | |of CAD Output” |

|4 | | |INCLUDE |ETID (TID nnn21.5) |1 |M | | |

| | | | |“Algorithm Identification” | | | | |

|5 | | |NUM |(cv, csd, “Certainty of |1 |U | |UNITS = (cv, csd, “Percent”) |

| | | | |feature”) | | | |Value = 0 – 100 |

|6 | | |NUM |(cv, csd, “Probability of |1 |UC |May be present only if parent is |UNITS = (cv, csd, “Percent”) |

| | | | |cancer”) | | |not “Non-lesion” |Value = 0 – 100 |

|7 | | |CODE |(cv, csd, “Pathology”) |1 |U | |DCID (CID 99143) “Pathology |

| | | | | | | | |Codes” |

|8 | | |CODE |(cv, csd, “Linear Measurement”) |1-n |U | |ECID (CID xxx16) “Linear |

| | | | | | | | |Measurements” |

|9 |> |HAS PROP |INCLUDE |ETID (TID nnn23.1) |1 |M | | |

| | | | |“Linear Measurement” | | | | |

|10| | |CODE |(cv, csd, “Area Measurement”) |1-n |U | |ECID (CID xxx17) “Area |

| | | | | | | | |Measurements” |

|11|> |HAS PROP |INCLUDE |ETID (TID nnn23.2) |1 |M | | |

| | | | |“Area Measurement” | | | | |

|12| | |CODE |(cv, csd, “Volume Measurement”) |1-n |U | |ECID (CID xxx18) “Volume |

| | | | | | | | |Measurements” |

|13|> |HAS PROP |INCLUDE |ETID (TID nnn23.3) |1 |M | | |

| | | | |“Volume Measurement” | | | | |

|14| | |INCLUDE |ETID (TID nnn25) |1-n |U | | |

| | | | |“Geometry” | | | | |

|15| | |CODE |(cv, csd, “Quantitative |1-n |UC |May be present only if “Composite|DCID (CID xxxx4) “Quantitative |

| | | | |Difference”) | | |type” is “temporal” |Temporal Difference Type” |

|16|> |HAS PROP |NUM |(cv, csd, “Difference value |1 |M | |UNITS = DCID (CID xxx19) “Units |

| | | | |A-B”) | | | |of 1D, 2D and 3D Measurement” or|

| | | | | | | | |(cv, csd, “Null”) |

|17|> |R-INFERRED |NUM | |2 |M | |The referenced numeric values |

| | |FROM | | | | | |shall have the same Concept |

| | | | | | | | |Name. Their UNITS shall be the |

| | | | | | | | |same as “Difference value A-B” |

|18| | |CODE |(cv, csd, “Qualitative |1-n |UC |May be present only if “Composite|DCID (CID xxxx4.1) “Qualitative |

| | | | |Difference”) | | |type” is “temporal” |Temporal Difference Type” |

|19|> |HAS PROP |TEXT |(cv, csd, “Description of |1 |M | | |

| | | | |Change”) | | | | |

|20|> |R-INFERRED |CODE | |2 |M | |The referenced code values shall|

| | |FROM | | | | | |have the same Concept Name and |

| | | | | | | | |be from the same context group. |

|21| | |CODE |(cv, csd, “Quadrant location”) |1 |U | |ECID (CID 99132) “Quadrant |

| | | | | | | | |Location” |

|22| | |CODE |(cv, csd, “Clockface or region”)|1 |U | |ECID (CID 99131) “Clockface |

| | | | | | | | |Location” |

|23| | |CODE |(cv, csd, “Depth”) |1 |U | |DCID (CID 99134) “Depth” |

|24| | |CODE |(cv, csd, “Lesion density”) |1 |UC |May be present only if parent is |DCID (CID 99120) “Density |

| | | | | | | |“Mass” or “Density” |Modifier” |

|25| | |CODE |(cv, csd, “Shape”) |1 |UC |May be present only if parent is |DCID (CID 99118) |

| | | | | | | |“Mass” or “Density” |“Characteristics of Shape” |

|26| | |CODE |(cv, csd, “Margins”) |1-n |UC |May be present only if parent is |DCID (CID 99119) |

| | | | | | | |“Mass” or “Density” |“Characteristics of Margin” |

|27| | |CODE |(cv, csd, “Calcification Type”) |1-n |UC |May be present only if parent is |DCID (CID 99121) “Calcification |

| | | | | | | |“Calcification Cluster” or |Types” |

| | | | | | | |“Individual Calcification” | |

|28| | |CODE |(cv, csd, “Calcification |1 |UC |May be present only if parent is |DCID (CID 99122) “Calcification |

| | | | |Distribution”) | | |“Calcification Cluster” |Distribution Modifier” |

|29| | |NUM |(cv, csd, “Number of |1 |UC |May be present only if parent is |UNITS = (cv, csd, “Null”) |

| | | | |calcifications”) | | |“Calcification Cluster” |Value = Integer 1 – n |

Content Item Descriptions

|Rendering Intent |This content item constrains the SCP receiving the Mammography CAD SR IOD in its use of the contents of |

| |this template and its target content items. CAD devices may opt to use data marked “Not for |

| |Presentation” or “Presentation Optional” as input to subsequent CAD processing steps. |

|Certainty of Feature |The likelihood that the feature analyzed, and classified by the CODE specified in the Composite Feature |

| |parent template, is in fact that type of feature. |

TID nnn9 Mammography CAD SR IOD Single Image Finding Template

This template collects a single image finding for a lesion or other object. The details of the finding are expressed in the Single Image Finding Generic (see TID nnn10) and/or more specific templates. The details from which a single image Calcification Cluster is inferred may be expressed in a number of Single Image Findings (see TID nnn9) of type Individual Calcification.

A Single Image Finding of type Breast Composition may be INFERRED FROM by-reference to a Single Image Finding of type Breast Geometry.

TID nnn9

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Single Image |1 |M | |ECID (CID 99126.1) “Single Image|

| | | | |Finding”) | | | |Finding” |

|2 |> |HAS PROP |CODE |(cv, csd, “Rendering Intent”) |1 |M | |ECID (CID xxxx1) “Intended Use |

| | | | | | | | |of CAD Output” |

|3 |> |HAS PROP |INCLUDE |ETID (TID nnn21.5) |1 |M | | |

| | | | |“Algorithm Identification” | | | | |

|4 |> |HAS PROP |INCLUDE |ETID (TID nnn10) |1 |MC |Shall be present only if parent | |

| | | | |“Single Image Finding Generic” | | |is not “Breast composition”, | |

| | | | | | | |“Breast geometry”, “Nipple”, | |

| | | | | | | |“Selected region” or “Image | |

| | | | | | | |quality” | |

|5 |> |HAS PROP |INCLUDE |ETID (TID nnn11) |1 |MC |Shall be present only if parent | |

| | | | |“Single Image Finding Breast | | |is “Breast composition” | |

| | | | |Composition” | | | | |

|6 |> |R-INFERRED |CODE |(cv, csd, “Single Image |1-n |UC |May be present only if parent is |EV (cv, csd, “Breast Geometry”) |

| | |FROM | |Finding”) | | |“Breast composition” |from CID 99126.1 |

|7 |> |HAS PROP |INCLUDE |ETID (TID nnn12) |1 |MC |Shall be present only if parent | |

| | | | |“Single Image Finding Breast | | |is “Breast geometry” | |

| | | | |Geometry” | | | | |

|8 |> |HAS PROP |INCLUDE |EDIT (TID nnn13.1) |1 |UC |May be present only if parent is | |

| | | | |“Single Image Finding Individual| | |“Individual Calcification” | |

| | | | |Calcification” | | | | |

|9 |> |HAS PROP |INCLUDE |ETID (TID nnn13.2) |1 |UC |May be present only if parent is | |

| | | | |“Single Image Finding | | |“Calcification Cluster” | |

| | | | |Calcification Cluster” | | | | |

|10|> |HAS PROP |INCLUDE |ETID (TID nnn14) |1 |UC |May be present only if parent is | |

| | | | |“Single Image Finding Density” | | |“Density” | |

|11|> |HAS PROP |INCLUDE |ETID (TID nnn15) |1 |MC |Shall be present only if parent | |

| | | | |“Single Image Finding Nipple” | | |is “Nipple” | |

|12|> |HAS PROP |INCLUDE |ETID (TID nnn16) |1 |MC |Shall be present only if parent | |

| | | | |“Single Image Finding | | |is “Non-lesion” | |

| | | | |Non-Lesion” | | | | |

|13|> |HAS PROP |INCLUDE |ETID (TID nnn17) |1 |MC |Shall be present only if parent | |

| | | | |“Selected Region” | | |is “Selected Region” | |

|14|> |HAS PROP |INCLUDE |ETID (TID nnn18) |1 |MC |Shall be present only if parent | |

| | | | |“Single Image Finding Image | | |is “Image quality” | |

| | | | |Quality” | | | | |

|15|> |INFERRED FROM|INCLUDE |ETID (TID nnn9) |1-n |UC |May be present only if parent is |EV (cv, csd, “Individual |

| | | | |“Single Image Finding” | | |“Calcification Cluster” |Calcification”) from CID 99126.1|

|16|> |HAS OBS |INCLUDE |ETID (TID 25) |1 |MC |Shall be present only if this | |

| | |CONTEXT | | | | |finding is quoted from a | |

| | | | | | | |different report. | |

Content Item Descriptions

|Rendering Intent |This content item constrains the SCP receiving the Mammography CAD SR IOD in its use of the contents of |

| |this template and its target content items. CAD devices may opt to use data marked “Not for |

| |Presentation” or “Presentation Optional” as input to subsequent CAD processing steps. |

|Single Image Finding |A Single Image Finding (whose parent is a Single Image Finding of type Calcification Cluster) allows one |

| |level of nesting for the definition of individual calcifications within the cluster. To use this |

| |template recursively, this Single Image Finding code value shall be “Individual Calcification”. |

TID nnn10 Mammography CAD SR IOD Single Image Finding Generic Template

The details of a single image finding are expressed in this template. It is applied to Single Image Findings (TID nnn9) of all types (CID 99126.1) except “Breast composition”, “Breast geometry”, “Nipple”, “Selected region” and “Image quality”.

TID nnn10

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING GENERIC

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |NUM |(cv, csd, “Certainty of |1 |U | |UNITS = (cv, csd, “Percent”) |

| | | | |Finding”) | | | |Value = 0 – 100 |

|2 | | |NUM |(cv, csd, “Probability of |1 |UC |May be present only if parent is |UNITS = (cv, csd, “Percent”) |

| | | | |Cancer”) | | |not “Non-lesion” |Value = 0 – 100 |

|3 | | |INCLUDE |ETID (TID nnn25) |1 |M | | |

| | | | |“Geometry” | | | | |

Content Item Descriptions

|Certainty of Finding |The likelihood that the finding detected, and classified by the CODE specified in the Single Image |

| |Finding parent template, is in fact that type of finding. |

TID nnn11 Mammography CAD SR IOD Single Image Finding Breast Composition Template

TID nnn11

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING BREAST COMPOSITION

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |NUM |(cv, csd, “Certainty of |1 |U | |UNITS = (cv, csd, “Percent”) |

| | | | |Finding”) | | | |Value = 0 – 100 |

|2 | | |CODE |(cv, csd, “Breast Composition”) |1 |MC |At least one of “Percent |DCID (CID 99115) “Overall Breast|

| | | | | | | |Glandular Tissue” or “Breast |Composition” |

| | | | | | | |Composition” shall be present | |

|3 | | |NUM |(cv, csd, “Percent Glandular |1 |MC |At least one of “Percent |UNITS = (cv, csd, “Percent”) |

| | | | |Tissue”) | | |Glandular Tissue” or “Breast |Value = 0 – 100 |

| | | | | | | |Composition” shall be present | |

Content Item Descriptions

|Certainty of Finding |The likelihood that the finding detected (CID 99115) is in fact that type of finding. |

|Percent Glandular Tissue |Percent of breast area that is mammographically dense |

TID nnn12 Mammography CAD SR IOD Single Image Finding Breast Geometry Template

TID nnn12

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING BREAST GEOMETRY

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |SCOORD |(cv, csd, “Breast Outline |1 |M | |Graphic Data Type = POLYLINE |

| | | | |Including Pectoral Muscle | | | | |

| | | | |Tissue”) | | | | |

|2 |> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

|3 | | |SCOORD |(cv, csd, “Pectoral Muscle |1 |U | |Graphic Data Type = POLYLINE |

| | | | |Outline”) | | | | |

|4 |> |R-SELECTED |IMAGE | |1 |M | |Shall reference the same node |

| | |FROM | | | | | |as Element 2 |

Content Item Descriptions

|Breast Outline Including Pectoral | |

|Muscle Tissue | |

|Pectoral Muscle Outline | |

TID nnn13.1 Mammography CAD SR IOD Single Image Finding Individual Calcification Template

This template provides the detail specific to an individual calcification.

TID nnn13.1

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING INDIVIDUAL CALCIFICATION

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Calcification type”) |1-n |MC |At least one of elements 1, 2, 4 |DCID (CID 99121) “Calcification |

| | | | | | | |shall be present |Types” |

|2 | | |CODE |(cv, csd, “Linear Measurement”) |1-n |MC |At least one of elements 1, 2, 4 |ECID (CID xxx16) “Linear |

| | | | | | | |shall be present |Measurements” |

|3 |> |HAS PROP |INCLUDE |ETID (TID nnn23.1) |1 |M | | |

| | | | |“Linear Measurement” | | | | |

|4 | | |CODE |(cv, csd, “Area Measurement”) |1-n |MC |At least one of elements 1, 2, 4 |ECID (CID xxx17) “Area |

| | | | | | | |shall be present |Measurements” |

|5 |> |HAS PROP |INCLUDE |ETID (TID nnn23.2) |1 |M | | |

| | | | |“Area Measurement” | | | | |

TID nnn13.2 Mammography CAD SR IOD Single Image Finding Calcification Cluster Template

This template provides the detail specific to a calcification cluster.

TID nnn13.2

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING CALCIFICATION CLUSTER

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Calcification type”) |1-n |MC |At least one of elements 1, 2, 3,|DCID (CID 99121) “Calcification |

| | | | | | | |4, 6 shall be present |Types” |

|2 | | |CODE |(cv, csd, “Calcification |1 |MC |At least one of elements 1, 2, 3,|DCID (CID 99122) “Calcification |

| | | | |distribution”) | | |4, 6 shall be present |Distribution Modifier” |

|3 | | |NUM |(cv, csd, “Number of |1 |MC |At least one of elements 1, 2, 3,|UNITS = (cv, csd, “Null”) |

| | | | |calcifications”) | | |4, 6 shall be present |Value = Integer >= 1 |

|4 | | |CODE |(cv, csd, “Linear Measurement”) |1-n |MC |At least one of elements 1, 2, 3,|ECID (CID xxx16) “Linear |

| | | | | | | |4, 6 shall be present |Measurements” |

|5 |> |HAS PROP |INCLUDE |ETID (TID nnn23.1) |1 |M | | |

| | | | |“Linear Measurement” | | | | |

|6 | | |CODE |(cv, csd, “Area Measurement”) |1-n |MC |At least one of elements 1, 2, 3,|ECID (CID xxx17) “Area |

| | | | | | | |4, 6 shall be present |Measurements” |

|7 |> |HAS PROP |INCLUDE |ETID (TID nnn23.2) |1 |M | | |

| | | | |“Area Measurement” | | | | |

TID nnn14 Mammography CAD SR IOD Single Image Finding Density Template

This template provides the detail specific to a density.

TID nnn14

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING DENSITY

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Lesion density”) |1 |MC |At least one of elements 1, 2, 3,|DCID (CID 99120) “Density |

| | | | | | | |4, 6 shall be present |Modifier” |

|2 | | |CODE |(cv, csd, “Shape”) |1 |MC |At least one of elements 1, 2, 3,|DCID (CID 99118) |

| | | | | | | |4, 6 shall be present |“Characteristics of Shape” |

|3 | | |CODE |(cv, csd, “Margins”) |1-n |MC |At least one of elements 1, 2, 3,|DCID (CID 99119) |

| | | | | | | |4, 6 shall be present |“Characteristics of Margin” |

|4 | | |CODE |(cv, csd, “Linear Measurement”) |1-n |MC |At least one of elements 1, 2, 3,|ECID (CID xxx16) “Linear |

| | | | | | | |4, 6 shall be present |Measurements” |

|5 |> |HAS PROP |INCLUDE |ETID (TID nnn23.1) |1 |M | | |

| | | | |“Linear Measurement” | | | | |

|6 | | |CODE |(cv, csd, “Area Measurement”) |1-n |MC |At least one of elements 1, 2, 3,|ECID (CID xxx17) “Area |

| | | | | | | |4, 6 shall be present |Measurements” |

|7 |> |HAS PROP |INCLUDE |ETID (TID nnn23.2) |1 |M | | |

| | | | |“Area Measurement” | | | | |

TID nnn15 Mammography CAD SR IOD Single Image Finding Nipple Template

This template provides the detail specific to a nipple.

TID nnn15

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING NIPPLE

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Nipple Status”) |1 |U | |DCID (CID xxxx5) “Nipple Status”|

|2 | | |SCOORD |(cv, csd, “Nipple Center”) |1 |M | |Graphic Data Type = POINT |

|3 |> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

Content Item Descriptions

|Nipple Center | |

TID nnn16 Mammography CAD SR IOD Single Image Finding Non-Lesion Template

This template provides the detail specific to a finding other than a lesion (see CID xxxx6).

TID nnn16

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING NON-LESION

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Object type”) |1 |M | |DCID (CID xxxx6) “Non-Lesion |

| | | | | | | | |Object Type” |

|2 | | |CODE |(cv, csd, “Linear Measurement”) |1-n |U | |ECID (CID xxx16) “Linear |

| | | | | | | | |Measurements” |

|3 |> |HAS PROP |INCLUDE |ETID (TID nnn23.1) |1 |M | | |

| | | | |“Linear Measurement” | | | | |

|4 | | |CODE |(cv, csd, “Area Measurement”) |1-n |U | |ECID (CID xxx17) “Area |

| | | | | | | | |Measurements” |

|5 |> |HAS PROP |INCLUDE |ETID (TID nnn23.2) |1 |M | | |

| | | | |“Area Measurement” | | | | |

TID nnn17 Mammography CAD SR IOD Single Image Finding Selected Region Template

This template provides the detail specific to a selected region. A selected region is any CAD derived arbitrary region of the image, whether within the breast outline or not. This can be use to delineate regions such as the intramammary fold.

TID nnn17

MAMMOGRAPHY CAD SR IOD SELECTED REGION

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |TEXT |(cv, csd, “Selected Region |1 |M | | |

| | | | |Description”) | | | | |

|2 | | |INCLUDE |ETID (TID nnn25) |1 |M | | |

| | | | |“Geometry” | | | | |

|3 | | |CODE |(cv, csd, “Linear Measurement”) |1-n |U | |ECID (CID xxx16) “Linear |

| | | | | | | | |Measurements” |

|4 |> |HAS PROP |INCLUDE |ETID (TID nnn23.1) |1 |M | | |

| | | | |“Linear Measurement” | | | | |

|5 | | |CODE |(cv, csd, “Area Measurement”) |1-n |U | |ECID (CID xxx17) “Area |

| | | | | | | | |Measurements” |

|6 |> |HAS PROP |INCLUDE |ETID (TID nnn23.2) |1 |M | | |

| | | | |“Area Measurement” | | | | |

TID nnn18 Mammography CAD SR IOD Single Image Finding Image Quality Template

This template provides the detail specific to image quality. It allows the encoding of descriptors of image quality (CID xxxx7) for a given image or region of an image. For instance, images with partial motion blur can be identified with the region noted.

TID nnn18

MAMMOGRAPHY CAD SR IOD SINGLE IMAGE FINDING IMAGE QUALITY

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | |R- |IMAGE | |1 |MC |Shall be present only if “Image |Shall reference an “Image Used |

| | | | | | | |Region” is not present |As Evidence” |

|2 | | |SCOORD |(cv, csd, “Image Region”) |1-n |MC |Shall be present only if Element | |

| | | | | | | |1 is not present | |

|3 |> |R-SELECTED |IMAGE | |1 |M | |Each “Image Region” shall |

| | |FROM | | | | | |reference the same “Image Used |

| | | | | | | | |As Evidence” |

|4 | | |NUM |(cv, csd, “Certainty of |1 |U | |UNITS = (cv, csd, “Percent”) |

| | | | |Finding”)1 | | | |Value = 0 – 100 |

|5 | | |CODE |(cv, csd, “Quality Finding”) |1 |M | |DCID (CID xxxx7) “Image Quality |

| | | | | | | | |Finding” |

|6 | | |CODE |(cv, csd, “Quality Control |1 |U | |DCID (CID xxx11) “Types of |

| | | | |Standard”) | | | |Quality Control Standard” |

|7 | | |CODE |(cv, csd, “Quality Assessment”) |1 |U | |DCID (CID xxx10) “Types of Image|

| | | | | | | | |Quality Assessment” |

|8 | | |NUM |(cv, csd, “Image Quality |1 |U | |UNITS = (cv, csd, “Null”) |

| | | | |Rating”)2 | | | |Value = 0 – 100 |

Content Item Descriptions

|Certainty of Finding |The likelihood that the finding detected (CID xxxx7) is in fact that type of finding. |

|Image Quality Rating |A numeric value in the range 0 to 100, inclusive, where 0 is poor quality and 100 is best quality. |

TID nnn19.1 Mammography CAD SR IOD Detections Performed Template

This template gathers two lists of detection algorithms attempted, grouped by success/failure status. Algorithms not attempted are not mentioned in this sub-tree of the Document Root (TID nnn1). This information forms the basis for understanding why a CAD report may produce no (or fewer than anticipated) detection results.

The sub-tree formed by this template is illustrated in Figure x.x.x.2 of Part 3, Annex X (Mammography CAD SR Content Tree Structure).

TID nnn19.1

MAMMOGRAPHY CAD SR IOD DETECTIONS PERFORMED

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |TEXT |(cv, csd, “Successful |1 |MC |Shall be present only if parent |NULL |

| | | | |Detections”) | | |is “Succeeded” or “Partially | |

| | | | | | | |Succeeded” | |

|2 |> |HAS PROP |INCLUDE |ETID (TID nnn20) |1-n |M | | |

| | | | |“Detection Performed” | | | | |

|3 | | |TEXT |(cv, csd, “Failed Detections”) |1 |MC |Shall be present only if parent |NULL |

| | | | | | | |is “Failed” or “Partially | |

| | | | | | | |Succeeded” | |

|4 |> |HAS PROP |INCLUDE |ETID (TID nnn20) |1-n |M | | |

| | | | |“Detection Performed” | | | | |

TID nnn19.2 Mammography CAD SR IOD Analyses Performed Template

This template gathers two lists of analysis algorithms attempted, grouped by success/failure status. Algorithms not attempted are not mentioned in this sub-tree of the Document Root (TID nnn1). This information forms the basis for understanding why a CAD report may produce no (or fewer than anticipated) analysis results.

The sub-tree formed by this template is illustrated in Figure x.x.x.2 of Part 3, Annex X (Mammography CAD SR Content Tree Structure).

TID nnn19.2

MAMMOGRAPHY CAD SR IOD ANALYSES PERFORMED

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |TEXT |(cv, csd, “Successful Analyses”)|1 |MC |Shall be present only if parent |NULL |

| | | | | | | |is “Succeeded” or “Partially | |

| | | | | | | |Succeeded” | |

|2 |> |HAS PROP |INCLUDE |ETID (TID nnn21) |1-n |M | | |

| | | | |“Analysis Performed” | | | | |

|3 | | |TEXT |(cv, csd, “Failed Analyses”) |1 |MC |Shall be present only if parent |NULL |

| | | | | | | |is “Failed” or “Partially | |

| | | | | | | |Succeeded” | |

|4 |> |HAS PROP |INCLUDE |ETID (TID nnn21) |1-n |M | | |

| | | | |“Analysis Performed” | | | | |

TID nnn20 Mammography CAD SR IOD Detection Performed Template

This template fully identifies a detection algorithm and the images and/or image regions on which it operated.

TID nnn20

MAMMOGRAPHY CAD SR IOD DETECTION PERFORMED

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Detection Performed”)|1 |M | |DCID (CID 99126.1) “Single Image|

| | | | | | | | |Finding” |

|2 |> |HAS PROP |INCLUDE |ETID (TID nnn21.5) |1 |M | | |

| | | | |“Algorithm Identification” | | | | |

|3 |> |R-HAS PROP |IMAGE | |1-n |MC |At least one of Element 3 or |Shall reference an “Image Used |

| | | | | | | |“Image Region” shall be present |As Evidence” |

|4 |> |HAS PROP |SCOORD |(cv, csd, “Image Region”) |1-n |MC |At least one of Element 3 or | |

| | | | | | | |“Image Region” shall be present | |

|5 |>> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

Content Item Descriptions

|Algorithm Identification |If more than one detection algorithm has the same “Detection Performed” code value (CID 99126.1) then the|

| |“Algorithm Identification” shall unambiguously distinguish between algorithms. |

TID nnn21 Mammography CAD SR IOD Analysis Performed Template

This template fully identifies an analysis algorithm and the images and/or image regions on which it operated.

TID nnn21

MAMMOGRAPHY CAD SR IOD ANALYSIS PERFORMED

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |CODE |(cv, csd, “Analysis Performed”) |1 |M | |DCID (CID xxxx9) “Types of CAD |

| | | | | | | | |Analysis Performed” |

|2 |> |HAS PROP |INCLUDE |ETID (TID nnn21.5) |1 |M | | |

| | | | |“Algorithm Identification” | | | | |

|3 |> |R-HAS PROP |IMAGE | |1-n |MC |A total of at least two instances|Shall reference an “Image Used |

| | | | | | | |of Element 3 or “Image Region” |As Evidence” |

| | | | | | | |shall be present | |

|4 |> |HAS PROP |SCOORD |(cv, csd. “Image Region”) |1-n |MC |At total of at least two | |

| | | | | | | |instances of Element 3 or “Image | |

| | | | | | | |Region” shall be present | |

|5 |>> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

Content Item Descriptions

|Algorithm Identification |If more than one analysis algorithm has the same “Analysis Performed” code value (CID xxxx9) then the |

| |“Algorithm Identification” shall unambiguously distinguish between algorithms. |

TID nnn21.5 Mammography CAD SR IOD Algorithm Identification Template

This template details the algorithm unambiguously. Re-state the software identification from the General Equipment Module of the Mammography CAD SR IOD if all algorithms are unambiguously defined by that module.

TID nnn21.5

MAMMOGRAPHY CAD SR IOD ALGORITHM IDENTIFICATION

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |TEXT |(cv, csd, “Algorithm ID”) |1 |M | | |

|2 | | |TEXT |(cv, csd, “Algorithm Version”) |1 |M | | |

|3 | | |TEXT |(cv, csd, “Algorithm |1-n |U | | |

| | | | |Parameters”) | | | | |

TID nnn22 Mammography CAD SR IOD Image Library Entry Template

Each instance of the Image Library Entry template contains the Image SOP Class and Instance UIDs, and selected attributes for an image. If the Image SOP Class is other than Digital Mammography Image Storage then as many of the attributes as possible should be derived.

TID nnn22

MAMMOGRAPHY CAD SR IOD IMAGE LIBRARY ENTRY

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |IMAGE |(cv, csd, “Image Used As |1 |M | | |

| | | | |Evidence”) | | | | |

|2 |> |HAS ACQ |CODE |(cv, csd, “Image Laterality”) |1 |MC |Shall be present if (0020,0062) |ECID (CID 99133) “Side” |

| | |CONTEXT | | | | |is in “Image Used As Evidence” | |

|3 |> |HAS ACQ |CODE |(cv, csd, “Image View Code |1 |MC |Shall be present if (0054,0220) |ECID (CID 4014) “View for |

| | |CONTEXT | |Sequence”) | | |is in “Image Used As Evidence” |Mammography” |

|4 |> |HAS ACQ |CODE |(cv, csd, “Image View Code |1 |MC |Shall be present if (0054,0222) |ECID (CID 4015) “View Modifier |

| | |CONTEXT | |Modifier Sequence”) | | |is in “Image Used As Evidence” |for Mammography” |

|5 |> |HAS ACQ |TEXT |(cv, csd, “Patient Orientation |1 |MC |Shall be present if (0020,0020) | |

| | |CONTEXT | |Row”) | | |is in “Image Used As Evidence” | |

|6 |> |HAS ACQ |TEXT |(cv, csd, “Patient Orientation |1 |MC |Shall be present if (0020,0020) | |

| | |CONTEXT | |Column”) | | |is in “Image Used As Evidence” | |

|7 |> |HAS ACQ |DATE |(cv, csd, “Study Date”) |1 |MC |Shall be present if (0008,0020) | |

| | |CONTEXT | | | | |is in “Image Used As Evidence” | |

|8 |> |HAS ACQ |TIME |(cv, csd, “Study Time”) |1 |MC |Shall be present if (0008,0030) | |

| | |CONTEXT | | | | |is in “Image Used As Evidence” | |

|9 |> |HAS ACQ |DATE |(cv, csd, “Content Date”) |1 |MC |Shall be present if (0008,0023) | |

| | |CONTEXT | | | | |is in “Image Used As Evidence” | |

|10|> |HAS ACQ |TIME |(cv, csd, “Content Time”) |1 |MC |Shall be present if (0008,0033) | |

| | |CONTEXT | | | | |is in “Image Used As Evidence” | |

|11|> |HAS ACQ |NUM |(cv, csd, “Horizontal Imager |1 |MC |Shall be present if (0018,1164) |EV (cv, csd, “μm”) |

| | |CONTEXT | |Pixel Spacing”) | | |is in “Image Used As Evidence” | |

|12|> |HAS ACQ |NUM |(cv, csd, “Vertical Imager Pixel|1 |MC |Shall be present if (0018,1164) |EV (cv, csd, “μm”) |

| | |CONTEXT | |Spacing”) | | |is in “Image Used As Evidence” | |

Content Item Descriptions

|Patient Orientation Row |First (row) and Second (column) components of Patient Orientation (0020,0020) in “Image Used As |

| |Evidence”. See PS 3, C.7.6.1.1.1. |

|Patient Orientation Column | |

|Horizontal Imager Pixel Spacing |The row (first) component of Imager Pixel Spacing (0018,1164) in “Image Used As Evidence”. See PS 3, |

| |C.8.11.4. If the source spacing is not microns, convert it. |

|Vertical Imager Pixel Spacing |The column (second) component of Imager Pixel Spacing (0018,1164) in “Image Used As Evidence”. See PS 3,|

| |C.8.11.4. If the source spacing is not microns, convert it. |

TID nnn23.1 Mammography CAD SR IOD Linear Measurement Template

TID nnn23.1

MAMMOGRAPHY CAD SR IOD LINEAR MEASUREMENT

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |TEXT |(cv, csd, “Measurement Name”) |1 |M | | |

|2 | | |NUM |(cv, csd, “Path length”) |1 |M | |UNITS = DCID (CID xxx13) “Units |

| | | | | | | | |of Linear Measurement” |

|3 |> |INFERRED FROM|SCOORD |(cv, csd, “Path”) |1 |M | | |

|4 |>> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

Content Item Descriptions

|Path |Path can be a POLYLINE with two points (to measure length, diameter, distance, proximity, etc), a CIRCLE |

| |or ELLIPSE (to measure circumference) or a POLYLINE (open or closed) to measure polyline length or |

| |perimeter. A Graphic Data Type of POINT implies that the object is a single pixel. |

TID nnn23.2 Mammography CAD SR IOD Area Measurement Template

TID nnn23.2

MAMMOGRAPHY CAD SR IOD AREA MEASUREMENT

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |TEXT |(cv, csd, “Measurement Name”) |1 |M | | |

|2 | | |NUM |(cv, csd, “Area”) |1 |M | |UNITS = DCID (CID xxx14) “Units |

| | | | | | | | |of Area Measurement” |

|3 |> |INFERRED FROM|SCOORD |(cv, csd, “Area Outline”) |1 |MC |Shall be present if code value of| |

| | | | | | | |parent of “Area” is “Area of | |

| | | | | | | |Defined Region” | |

|4 |>> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

Content Item Descriptions

|Area Outline |A Graphic Data Type of POINT implies that the object is a single pixel. |

TID nnn23.3 Mammography CAD SR IOD Volume Measurement Template

TID nnn23.3

MAMMOGRAPHY CAD SR IOD VOLUME MEASUREMENT

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |TEXT |(cv, csd, “Measurement Name”) |1 |M | | |

|2 | | |NUM |(cv, csd, “Volume”) |1 |M | |UNITS = DCID (CID xxx15) “Units |

| | | | | | | | |of Volume Measurement” |

|3 |> |INFERRED FROM|SCOORD |(cv, csd, “Perimeter Outline”) |1-n |U | | |

|4 |>> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

Content Item Descriptions

|Perimeter Outline |The perimeter of the volume’s projection into the image. |

TID nnn25 Mammography CAD SR IOD Geometry Template

TID nnn25

MAMMOGRAPHY CAD SR IOD GEOMETRY

| |NL |Rel with |VT |Concept Name |VM |Req |Condition |Value Set Constraint |

| | |Parent | | | |Type | | |

|1 | | |SCOORD |(cv, csd, “Center”) |1 |M | |Graphic Data Type = POINT |

|2 |> |R-SELECTED |IMAGE | |1 |M | |Shall reference an “Image Used |

| | |FROM | | | | | |As Evidence” |

|3 | | |SCOORD |(cv, csd, “Outline”) |1 |U | | |

|4 |> |R-SELECTED |IMAGE | |1 |M | |Shall reference the same node as|

| | |FROM | | | | | |Element 2 |

ANNEX Y: Mammography CAD SR IOD Adoptive terminology and NOMENCLATURE

BI-RADS( Terminology and Nomenclature:

Terminology used within the Mammography CAD SR SOP Class is a superset of BI-RADS( Revision 3, a trademarked lexicon of Mammography screening terminology and nomenclature licensed by DICOM from the American College of Radiology. BI-RADS( publications are available from the American College of Radiology. The DICOM standard does not require Mammography CAD SR SOP Class implementations to adhere to BI-RADS(.

MQCM 1999 Terminology and Nomenclature

References to MQCM 1999 are made in the description of the Mammography CAD SR SOP Class. In this MQCM 1999 refers to the Mammography Quality Control Manual 1999, available from the American College of Radiology. This document describes a standardized approach to mammographic acquisition standards, patient positioning, and so on. The DICOM standard does not require Mammography CAD SR SOP Class implementations to adhere to MQCM 1999.

MQSA Terminology and Nomenclature

References to MQSA are made in the description of the Mammography CAD SR SOP Class. In this MQSA refers to the Mammography Quality Standards Act final rules. While MQSA is a federal regulation of the United States government, it provides the only widely published standards for mammographic quality and is incorporated in this document for that reason. The DICOM standard does not require Mammography CAD SR SOP Class implementations to adhere to MQSA.

ANNEX Z: Mammography CAD SR IOD MICROGLOSSARY

The following tables provide context identification (Context Id) information derived from SNOMED for DICOM.

CONTEXT GROUP 99115 – Overall Breast Composition

Note from National Mammography Database (BI-RADSTM 3.0, E77)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Almost entirely fat |

| | |Scattered fibroglandular densities |

| | |Heterogeneously dense |

| | |Extremely dense |

CONTEXT GROUP 99117 – Change Since Last Mammogram or Prior Surgery

Note from National Mammography Database (BI-RADSTM 3.0, E79)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |New finding |

| | |Finding partially removed |

| | |No significant changes in the finding |

| | |Increase in size |

| | |Decrease in size |

| | |Increase in number of calcifications |

| | |Decrease in number of calcifications |

| | |Less defined |

| | |More defined |

| | |Implant removed |

| | |Implant revised |

CONTEXT GROUP 99118 – Characteristics of Shape

Note from National Mammography Database (BI-RADSTM 3.0, E80)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Round |

| | |Oval |

| | |Lobular |

| | |Irregular |

CONTEXT GROUP 99119 – Characteristics of Margin

Note from National Mammography Database (BI-RADSTM 3.0, E81)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Circumscribed (well-defined or sharply-defined) |

| | |Microlobulated |

| | |Obscured |

| | |Indistinct |

| | |Spiculated |

CONTEXT GROUP 99120 – Density Modifier

Note from National Mammography Database (BI-RADSTM 3.0, E82)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |High density |

| | |Equal density (isodense) |

| | |Low density (not containing fat) |

| | |Fat containing (radiolucent) |

CONTEXT GROUP 99121 – Calcification Types

Note from National Mammography Database (BI-RADSTM 3.0, E83)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Coarse (popcorn-like) |

| | |Dystrophic |

| | |Eggshell or rim |

| | |Large rod-like |

| | |Milk of calcium |

| | |Lucent-centered |

| | |Punctate |

| | |Round |

| | |Skin |

| | |Suture |

| | |Vascular |

| | |Amorphous or indistinct |

| | |Fine, linear (casting) |

| | |Fine, linear, branching (casting) |

| | |Heterogeneous or pleomorphic |

CONTEXT GROUP 99122 – Calcification Distribution Modifier

Note from National Mammography Database (BI-RADSTM 3.0, E84)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Diffuse/scattered |

| | |Linear |

| | |Grouped or clustered |

| | |Regional |

| | |Segmental |

CONTEXT GROUP 99126.1 – Single Image Finding

Note from National Mammography Database (BI-RADSTM 3.0)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Density |

| | |Individual Calcification |

| | |Calcification Cluster |

| | |Architectural distortion |

| | |Tubular density |

| | |Intra-mammary lymph node |

| | |Trabecular thickening |

| | |Selection region |

| | |Breast composition |

| | |Breast geometry |

| | |Nipple |

| | |Skin retraction |

| | |Skin thickening |

| | |Axillary adenopathy |

| | |Skin lesion |

| | |Non-lesion |

| | |Image Quality |

CONTEXT GROUP 99126.2 – Composite Feature

Note from National Mammography Database (BI-RADSTM 3.0)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Include CONTEXT GROUP 99126.1 |

| | |Mass |

| | |Focal asymmetric breast tissue |

| | |Asymmetric breast tissue |

CONTEXT GROUP 99131 – Clockface Location

Note from National Mammography Database (BI-RADSTM 3.0, E96)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |1 o’clock (1) |

| | |2 o’clock (2) |

| | |3 o’clock (3) |

| | |4 o’clock (4) |

| | |5 o’clock (5) |

| | |6 o’clock (6) |

| | |7 o’clock (7) |

| | |8 o’clock (8) |

| | |9 o’clock (9) |

| | |10 o’clock (10) |

| | |11 o’clock (11) |

| | |12 o’clock (12) |

| | |Subareolar (S) |

| | |Axillary tail (T) |

| | |Central (C) |

CONTEXT GROUP 99132 – Quadrant Location

Note from National Mammography Database (BI-RADSTM 3.0, E97)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Upper outer (UO) |

| | |Upper inner (UI) |

| | |Lower outer (LO) |

| | |Lower inner (LI) |

CONTEXT GROUP 99133 – Side

Note from National Mammography Database (BI-RADSTM 3.0, E98)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Left |

| | |Right |

| | |Both |

CONTEXT GROUP 99134 – Depth

Note from National Mammography Database (BI-RADSTM 3.0, E99)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Anterior |

| | |Middle |

| | |Posterior |

CONTEXT GROUP 99135 – Assessment

Note from National Mammography Database (BI-RADSTM 3.0, E100)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |0 - Need additional imaging evaluation |

| | |1 – Negative |

| | |2 – Benign |

| | |3 - Probably benign – short interval follow-up (1-11 months) |

| | |4 - Suspicious abnormality, biopsy should be considered |

| | |5 - Highly suggestive of malignancy, take appropriate action |

CONTEXT GROUP 99136 – Recommended Follow-up

Note from National Mammography Database (BI-RADSTM 3.0, E101) for Assessment Category 0

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Additional projections (P) |

| | |Magnification views (M) |

| | |Spot compression (S) |

| | |Spot magnification (V) |

| | |Ultrasound (U) |

| | |Old films for comparison (O) |

| | |Ductography (G) |

| | |Normal interval follow-up (N) |

| | |Decision to biopsy should be based on clinical assessment |

| | |Follow-up at short interval (1-11 months) (F) |

| | |Biopsy should be considered (B) |

| | |Needle localization and biopsy (L) |

| | |Histology using core biopsy (H) |

| | |Suggestive of malignancy – take appropriate action (T) |

| | |Cytologic analysis (Y) |

CONTEXT GROUP 99143 – Pathology Codes

Note from National Mammography Database (BI-RADSTM 3.0, F110)

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Papilloma |

| | |Adenomyoepithelioma |

| | |Mixed tumor (pleomorphic adenoma) |

| | |Ductal adenoma |

| | |Florid papillomatosis (adenoma) of the nipple |

| | |Tubular adenoma |

| | |Lactating adenoma |

| | |Apocrine adenoma |

| | |Fibroadenoma |

| | |Fibroadenoma, NOS |

| | |Juvenile fibroadenoma |

| | |Benign cystosarcoma phyllodes (phyllodes tumor) |

| | |Hemangioma |

| | |Perilobular hemangioma |

| | |Hemangioma NOS |

| | |Venous hemangioma |

| | |Nonparenchymal subcutaneous hemangioma |

| | |Angiomatosis |

| | |Fibromatosis |

| | |Myofibroblastoma |

| | |Neurofibroma |

| | |Leiomyoma |

| | |Lipoma |

| | |Adenolipoma |

| | |Angiolipoma |

| | |Chondroma |

| | |Granular cell tumor |

| | |Ductal hyperplasia |

| | |Atypical ductal hyperplasia |

| | |Lobular hyperplasia |

| | |Atypical lobular hyperplasia |

| | |Adenosis |

| | |Sclerosing adenosis |

| | |Adenosis tumor |

| | |Microglandular adenosis |

| | |Tubular adenosis |

| | |Cysts |

| | |Fibroadenomatoid hyperplasia |

| | |Radial sclerosing lesion (radial scar) |

| | |Ductal ectasia |

| | |Inflammatory pseudotumor |

| | |Foreign body reaction |

| | |Fat necrosis |

| | |Infarct |

| | |Infection |

| | |Hamartoma |

| | |Gynecomastia |

| | |Juvenille papillomatosis |

| | |Fibrous tumor |

| | |Diabetic mastopathy |

| | |Amyloid tumor |

| | |Pseudoangiomatous stromal hyperplasia |

| | |Asynchronous involution |

| | |Virginal hyperplasia |

| | |Intraductal carcinoma |

| | |Lobular carcinoma in situ |

| | |Invasive ductal carcinoma |

| | |Invasive ductal carcinoma w/ predominant intraductal component |

| | |Invasive lobular carcinoma |

| | |Medullary carcinoma |

| | |Mucinous carcinoma |

| | |Invasive papillary carcinoma |

| | |Tubular carcinoma |

| | |Adenoid cystic carcinoma |

| | |Secretory (juvenille) carcinoma |

| | |Apocrine carcinoma |

| | |Carcinoma with metaplasia |

| | |Carcinoma with osteoclast-like giant cells |

| | |Cystic hypersecretory carcinoma with invasion |

| | |Carcinoma with endocrine differentiation |

| | |Glycogen-rich carcionoma |

| | |Lipid-rich (lipid-secreting) carcinoma |

| | |Invasive cribriform carcinoma |

| | |Inflammatory carcinoma |

| | |Carcinoma in pregnancy and lactation |

| | |Occult carcinoma presenting with axillary lymph node metastases |

| | |Carcinoma in ectopic breast |

| | |Carcinoma in males |

| | |Carcinoma in children |

| | |Paget disease of nipple |

| | |Malignant cystosarcoma phyllodes |

| | |Angiosarcoma |

| | |Fibrosarcoma |

| | |Leiomyosarcoma |

| | |Chondrosarcoma |

| | |Osteosarcoma |

| | |Hemangiopericytoma |

| | |Dermatofibrosarcoma protuberans |

| | |Malignant melanoma of nipple |

| | |Squamous carcinoma of nipple |

| | |Basal cell carcinoma of nipple |

| | |Neoplasms of mammary skin |

| | |Non-Hodgkin lymphoma |

| | |Plasmacytoma |

| | |Leukemic infiltration |

| | |Hodgkin disease |

CONTEXT GROUP xxxx1 – Intended Use of CAD Output

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Presentation Required: Rendering device is expected to present |

| | |Presentation Optional: Rendering device may present |

| | |Not for Presentation: Rendering device expected not to present |

CONTEXT GROUP xxxx2 – Composite Feature Relations

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Target content items are related temporally |

| | |Target content items are related spatially |

| | |Target content items are related contra-laterally |

CONTEXT GROUP xxxx3 – Scope of Feature

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Feature detected on the only image |

| | |Feature detected on only one of the images |

| | |Feature detected on multiple images |

| | |Feature detected on images from multiple modalities |

CONTEXT GROUP xxxx4 – Quantitative Temporal Difference Type

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Size |

| | |Opacity |

| | |Location |

| | |Spatial Proximity |

| | |Number of calcifications |

CONTEXT GROUP xxxx4.1 – Qualitative Temporal Difference Type

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Shape |

| | |Margin |

| | |Symmetry |

CONTEXT GROUP xxxx5 – Nipple Status

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Normal |

| | |Nipple Retraction |

CONTEXT GROUP xxxx6 – Non-Lesion Object Type

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Implant |

| | |Scar Tissue |

| | |Lead Pellet (BB) |

| | |Lead Marker |

| | |Bullet |

| | |J Wire |

| | |Staple |

| | |Suture |

| | |Clip |

| | |Pacemaker |

| | |Catheter |

| | |Paddle |

| | |Collimator |

| | |ID Plate |

| | |Contrast Agent |

| | |Other Marker |

| | |Unspecified |

CONTEXT GROUP xxxx7 – Image Quality Finding

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Lead Marker is missing1 |

| | |Lead Marker doesn’t have view and laterality2 |

| | |Lead Marker doesn’t have FDA approved codes2 |

| | |Lead Marker is not near the axilla2 |

| | |Lead Marker is partially obscured2 |

| | |Lead Marker is incorrect |

| | |Lead Marker is off film |

| | |Flash is not near edge of film2 |

| | |Flash is illegible, does not fit, or is lopsided1 |

| | |Flash doesn’t include patient name and additional patient id2 |

| | |Flash doesn’t include date of examination2 |

| | |Flash doesn’t include facility name and location1 |

| | |Flash doesn’t include technologist identification2 |

| | |Flash doesn’t include cassette/screen/detector identification2 |

| | |Flash doesn’t include mammography unit identification2 |

| | |Date sticker is missing2 |

| | |Technical factors missing2 |

| | |Collimation too close to breast2 |

| | |Inadequate compression2 |

| | |MLO Insufficient pectoral muscle2 |

| | |MLO No fat is visualized posterior to fibroglandular tissues2 |

| | |MLO Poor separation of deep and superficial breast tissues2 |

| | |MLO Evidence of motion blur2 |

| | |MLO Inframammary fold is not open2 |

| | |CC Not all medial tissue visualized2 |

| | |CC Nipple not centered on image2 |

| | |CC Posterior nipple line does not measure within 1 cm of MLO2 |

| | |Insufficient implant displacement incorrect2 |

| | |Image artifact |

| | |Grid artifacts |

| | |Positioning |

| | |Patient motion |

| | |Under exposed |

| | |Over exposed |

| | |No image |

| | |Detector artifacts |

| | |Artifacts other than detector artifacts |

| | |Mechanical failure |

| | |Electrical failure |

| | |Software failure |

| | |Image processing failure |

| | |Other failure |

| | |Unknown failure |

1 From MQSA

2 From MQCM 1999

CONTEXT GROUP xxxx8 – Status of Results

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Succeeded |

| | |Partially Succeeded |

| | |Failed |

| | |Not Attempted |

CONTEXT GROUP xxxx9 – Types of CAD Analysis Performed

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Spatial Colocation Analysis1 |

| | |Spatial Proximity Analysis2 |

| | |Temporal Correlation |

| | |Image Quality Analysis |

| | |Focal Asymmetric Density |

| | |Asymmetric Breast Tissue Analysis |

| | |Breast Composition Analysis |

1 Spatial Co-location Analysis is used to identify features that are the same or located in the same place.

2 Spatial Proximity Analysis is used to identify features that are related spatially, such as nipple retraction associated with a spiculated mass.

CONTEXT GROUP xxx10 – Types of Image Quality Assessment

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Unusable ( Quality renders image unusable |

| | |Usable ( Does not meet the quality control standard |

| | |Usable ( Meets the quality control standard |

CONTEXT GROUP xxx11 – Types of Quality Control Standard

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Mammography Quality Control Manual 1999, ACR |

| | |Title 21 CFR Section 900, Mammography … |

CONTEXT GROUP xxx12 – Units of Follow-up Interval

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Days |

| | |Weeks |

| | |Months |

| | |Years |

CONTEXT GROUP xxx13 – Units of Linear Measurement

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |cm |

| | |mm |

| | |(m |

CONTEXT GROUP xxx14 – Units of Area Measurement

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |cm2 |

| | |mm2 |

| | |(m2 |

CONTEXT GROUP xxx15 – Units of Volume Measurement

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |cm3 |

| | |mm3 |

| | |(m3 |

CONTEXT GROUP xxx16 – Linear Measurements

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Length |

| | |Width |

| | |Depth |

| | |Diameter |

| | |Long Axis |

| | |Short Axis |

| | |Major Axis |

| | |Minor Axis |

| | |Perpendicular Axis |

| | |Diameter |

| | |Radius |

| | |Perimeter |

| | |Circumference |

| | |Diameter of circumscribed circle |

CONTEXT GROUP xxx17 – Area Measurements

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Area |

| | |Area of defined region |

CONTEXT GROUP xxx18 – Volume Measurements

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |Volume |

| | |Volume of sphere |

| | |Volume of ellipsoid |

| | |Volume of circumscribed sphere |

| | |Volume of bounding three dimensional region |

CONTEXT GROUP xxx19 – Units of 1D, 2D and 3D Measurement

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

|Include CONTEXT GROUP xxx13 |

|Include CONTEXT GROUP xxx14 |

|Include CONTEXT GROUP xxx15 |

CONTEXT GROUP xxx20 – CAD Processing Summary

|Coding Scheme Designator |Code Value |Code Meaning |

|(0008,0102) |(0008,0100) |(0008,0104) |

| | |All algorithms succeeded; without findings |

| | |All algorithms succeeded; with findings |

| | |Not all algorithms succeeded; without findings |

| | |Not all algorithms succeeded; with findings |

| | |No algorithms succeeded; without findings |

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HAS OBS CONTEXT

( ( (

( ( (

HAS PROPERTIES

INFERRED FROM

HAS PROPERTIES

Composite Feature (Code)

Single Image Finding 1 (Code)

Single Image Finding 2 (Code)

Quoted Document Context Info.

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