Circle Cardiovascular Imaging (cvi42)

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	Circle Cardiovascular Imaging (cvi42) is cardiovascular post-processing software for viewing and analyzing Cardiovascular Magnetic Resonance (CMR) and Cardiac Computed Tomography (CCT) images. This technology is designed for both clinical and research use, and provides full Digital Imaging and Communications in Medicine (DICOM) and Picture Archiving and Communication System (PACS) connectivity. This technology connects to the hospital`s PACS. The server pulls DICOM data from the PACS system and the client manipulates that data. Changes are saved separately in workspace files on the server, and those workspace files are saved back to PACS. Data from PACS is stored on the server until the user deletes the data. All of this takes place on VA hospital computers, on premise, within VA`s own network. Additionally, this technology contains a small internal SQLite database, which can store sensitive data. This technology can integrate with Microsoft Structured Query Language (SQL) Server and SQLite database.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:	This technology has been assessed by the Section 508 Office and found non-conformant. The Implementer of this technology has the responsibility to ensure the version deployed is 508-compliant. Section 508 compliance may be reviewed by the Section 508 Office and appropriate remedial action required if necessary. For additional information or assistance regarding Section 508, please contact the Section 508 Office at Section508@va.gov. Please see reference tab for more information concerning product versions.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v24.4
Decision Date:	04/18/2024 at 18:19:36 UTC
Aliases:	cvi42
Introduced By:	TRM Request
Vendor Name:	Circle Cardiovascular Imaging

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Technology, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
5.1	02/05/2015
5.2	09/01/2015
5.3.x	03/16/2016
5.6.x	05/01/2017
5.10.x	11/30/2018
5.11.x	07/25/2019
5.12.x	02/20/2020
5.13.x	12/09/2020
5.14.x
5.16.x
5.17.x	03/30/2023
6.0.x	01/16/2024

Current Decision Matrix (04/15/2024)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

<Past

CY2023

CY2024

CY2025

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

5.1

Unapproved

5.2

Unapproved

5.3.x

Unapproved

5.6.x

Unapproved

5.10.x

Unapproved

5.11.x

Unapproved

5.12.x

Divest
[2, 11, 12, 13, 14]

Divest
[3, 11, 13, 15, 16]

Divest
[3, 13, 15, 16, 17]

Unapproved

5.13.x

Divest
[2, 11, 12, 13, 14]

Divest
[3, 11, 13, 15, 16]

Divest
[3, 13, 15, 16, 17]

Unapproved

5.14.x

Approved w/Constraints
[2, 11, 12, 13, 14]

Divest
[3, 11, 13, 15, 16]

Divest
[3, 13, 15, 16, 17]

Divest
[3, 16, 17, 18, 19]

Unapproved

5.16.x

Unapproved

Divest
[3, 11, 13, 15, 16]

Divest
[3, 13, 15, 16, 17]

Divest
[3, 16, 17, 18, 19]

Unapproved

5.17.x

Unapproved

Approved w/Constraints
[3, 11, 13, 15, 16]

Approved w/Constraints
[3, 13, 15, 16, 17]

Divest
[3, 16, 17, 18, 19]

Unapproved

6.0.x

Unapproved

Approved w/Constraints
[3, 16, 17, 18, 19]

Decision Constraints


[1]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[2]	If free trialware is utilized, the software must be purchased or removed at the end of the trial period.

[3]	Technology must remain patched and operated in accordance with Federal and Department security policies and guidelines in order to mitigate known and future security vulnerabilities.

[4]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[5]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[6]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[7]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[8]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[9]	Users should check with their supervisor, Information Security Office (ISO) or local OIT representative for permission to download and use this software. Downloaded software must always be scanned for viruses prior to installation to prevent adware or malware. Freeware may only be downloaded directly from the primary site that the creator of the software has advertised for public download and user or development community engagement. Users should note, any attempt by the installation process to install any additional, unrelated software is not approved and the user should take the proper steps to decline those installations.

[10]	Due to National Institute of Standards and Technology (NIST) identified security vulnerabilities, extra vigilance should be applied to ensure the versions remain properly patched to mitigate known and future vulnerabilities. The local ISO can provide assistance in reviewing the NIST vulnerabilities.

[11]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information System Security Officer (ISSO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[12]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with VA Handbook 6500.

[13]	Users should check with their supervisor, Information System Security Officer (ISSO) or local OIT representative for permission to download and use this software. Downloaded software must always be scanned for viruses prior to installation to prevent adware or malware. Freeware may only be downloaded directly from the primary site that the creator of the software has advertised for public download and user or development community engagement. Users should note, any attempt by the installation process to install any additional, unrelated software is not approved and the user should take the proper steps to decline those installations.

[14]	Due to National Institute of Standards and Technology (NIST) identified security vulnerabilities, extra vigilance should be applied to ensure the versions remain properly patched to mitigate known and future vulnerabilities. The local ISSO (Information System Security Officer) can provide assistance in reviewing the NIST vulnerabilities.

[15]	If free trialware is utilized, the software must be purchased or removed at the end of the trial period. Users must ensure that Microsoft Structured Query Language (SQL) Server is implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) This technology can potentially use Bitmap, a divested technology. Cvi42 is not Federal Information Processing Standards (FIPS) 140-2 certified. This technology will require third party FIPS 140-2 certified solution for any data containing PHI/PII or VA sensitive information.

[16]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with both VA Handbook 6500 and VA Directive 6500.

[17]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 or its successor to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 or 140-3 compliant full disk encryption (FOE) must be implemented on the storage device where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information System Security Officer (ISSO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP). By September 22, 2026, all FIPS 140-2 certificate validations will be placed on the Historical List, please refer to FIPS Transition Effort for further guidance and timeline of changes.

[18]	Users must ensure that Google Chrome, Microsoft Edge, and Microsoft Structured Query Language (SQL) Server are implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’) Users must not utilize Bitmap Image File (BMP), as it is at the time of writing, in a divested state within the TRM. Users must not utilize the Secure Sockets Layer (SSL) protocol, as it is unapproved for use on the TRM.

[19]	The Federal Information Processing standards (FIPS) 140-2 certification status of this technology was not able to be verified. This technology will require a 3rd party FIPS 140-2 or 140-3 certified solution for any data containing PHI/PII or VA sensitive information, where applicable. More information regarding the Cryptographic Module Validation Program (CMVP) can be found on the NIST website.

Note:

At the time of writing, version 6.0.2 is the most current version, released 01/24/2024.

References

The following reference(s) are associated with this entry:
Type	Name	Source	Description
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Technology Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Name	Description
Aortic Valve Module	The Aortic Value Module is designed to offer a structured workflow for pre-procedural planning, and allows users to switch between phases during assessment of multiphase Computed Tomography (CT).
Calcium Sorting Module	The Calcium Sorting Module allows users to quantify the coronary artery plaque load; detect calcium and assign to a specific coronary.
Flow Module	The Flow Module defines vessel contours in all phases and applies background correction. Users can compare two flow series at once and automatically calculate Qp/Qs.
Four-Dimensional (4D) Viewer Module	The four-dimensional (4D) Viewer Module is designed to view and analyze three-dimensional (3D) and 4D data such as Magnetic Resonance (MR) and CT angiography.
Heart Function Module	The Heart Function Module calculates values for Left Ventricle (LV) function using the following approaches: Bi/Triplanar, Long Axis, and Short Axis.
Multiplanar Reformation Module	The Multiplanar Reformation Module allows users to reconstruct a slice in any position or orientation through the 3D volume. Users can reconstruct axial images into coronal, sagittal, and oblique anatomical planes.
Perfusion Module	The Perfusion Module is designed to visualize the inflow of contrast-media enhanced blood into the myocardium.
Report Module	The Report Module allows users to create scientific or clinical reports from analysis completed in cvi42. Users can edit patient data and annotations, add comments and images, customize the header, and generate canned text.
T1 Mapping Module	The T1 Mapping Module allows users to directly quantify T1 relaxation time values for identical images with different times of inversion at end-diastole of consecutive heartbeats.
T2 Mapping Module	The T2 Mapping Module defines endo and epicardial contours for global T2 values and defines the septal wall region of interest (ROI) for regional T2 values.
Tissue Characterization Module	The Tissue Characterization Module assesses the extent and regional distribution of injury (scar, edema, inflammation) to the heart.
Vessel Module	The Vessel Module allows users to view, create, and edit vessel segmentations and labels. Users can analyze windows for lumen measurements and coronary artery or valve stenosis assessment.
Viewer and Series Composer Module	Users can customize how studies are viewed with the Viewer, compare two different studies at once, and manually generate a new series via drag-and-drop with the Series Composer.
WebClient Server	WebClient Server is a new component, introduced in 6.0 to support cvi42 Web Viewer.
WebClient Worker	WebClient Worker is a new component introduced in 6.0, that works in conjunction with cvi42 WebClient Server to support cvi42 Web Viewer.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Health Care Health Services	Imaging
Health Care Health Services	Medicine Services

Operating Systems Supported by the Technology

macOS - Approved w/Constraints
Windows Client - Approved w/Constraints
Windows Server - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

At the time of writing, no National Institute of Standards and Technology (NIST) vulnerabilities had been reported and no VA Cyber Security Operations Center (CSOC) bulletins had been issued for the latest versions of this technology.
This technology allows for all source data to be exported to a number of industry standard file formats.
This technology may improve productivity for specific staff whose responsibilities include interpreting cardiac exams.
This is a well-documented technology.

Adoption Risks

There is no indication based on either the vendor documentation or the Cryptographic Module Validation Program (CMVP) that this technology is Federal Information Processing Standard (FIPS) 140-2 compliant.
The potential exists to store Personally Identifiable Information (PII), Protected Health Information (PHI) and/or VA Sensitive data and proper security standards must be followed in these cases.
Bitmap Image File (BMP), an optional dependency of this technology, is in a divested state at the time of writing.
Due to the rapid release schedule of this technology, the VA may be unable to update to the most recent patch and may require a deployment model requiring the use of specific versions.
This technology can integrate with and alter database technologies.

Architectural Benefits

This technology can use a VA-preferred database.
This technology is portable as it runs on multiple TRM-approved operating systems.
This technology conforms to the DICOM standard and supports interoperability between different applications supporting compatible DICOM functionality.

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Companion Technologies/Supported Standards:

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