Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.

Device Description

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic root and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.

It allows cardiologists, radiologists and clinical specialists to select patient CT studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. It provides assessment and measurement of different structures of the heart and vessels relevant to approach planning. It provides simple techniques to assess the feasibility of a trans-apical, iliac, or subclavian approach to heart structures for replacement or repair procedures.

AI/ML Overview

The provided text describes Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning, a non-invasive post-processing application. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Pie Medical Imaging B.V., 3mensio Workstation (K120367)) rather than establishing specific acceptance criteria and proving performance against them in a detailed study.

Therefore, much of the requested information (acceptance criteria, reported performance values, specific sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study details, ground truth types) is not explicitly stated in the provided document in the format typically associated with a robust performance study.

However, based on the non-clinical testing section and external validation summary, we can infer some aspects and report what is available.

1. ⁠Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria with corresponding reported device performance values. Instead, it describes general validation goals and outcomes.

Feature/Functionality	Acceptance Criteria (Inferred from Validation Goals)	Reported Device Performance
Accuracy of spatial measurements (distance, angle)	Spatial accuracy of image rendering, distance, angular measurement, and navigational tools aligned with known values from imaging phantoms.	Verified using imaging phantoms with known positions, distances, and angles. Specific numerical accuracy values are not provided, but the verification confirmed alignment with expected results for spatial accuracy, distance measurement, angular measurement, navigational tools, and orientation markers.
Accuracy of automated segmentation for 3D anatomical representation	Automated segmentation should enable accurate 3D representation of relevant anatomy.	During external validation with 70 TAVR cases, "Each user felt that the automated segmentation within the application enabled an accurate 3D representation of the relevant anatomy."
Accuracy of automated oblique for annulus valve plane	Automated oblique should provide an accurate starting point for determining the annulus valve plane.	During external validation with 70 TAVR cases, "The users also felt the automated oblique provided an accurate starting point for determining the annulus valve plane."
User ability to review, verify, adjust, measure, and report	Users should be able to effectively use the software's tools (review 2D/3D images, verify/correct segmentation, create measurements, generate reports).	During external validation with 70 TAVR cases, "All of the users were able to review the 2D and 3D images, verify and correct the results of segmentations and initialization, create measurements, and generate reports."

2. ⁠Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 70 TAVR cases were used for "External Validation."
Data Provenance: Not explicitly stated (e.g., country of origin, specific institutions). It is referred to as "previously acquired medical images," suggesting a retrospective nature, but this is not explicitly confirmed. The type of study is "non-clinical tests" and "evaluation of previously acquired medical images."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified. The document states that "external cardiologists and radiologists evaluated 70 TAVR cases" during external validation. It does not clarify how many individual experts were involved.
Qualifications of Experts: "External cardiologists and radiologists." No specific details on their years of experience or expertise are provided beyond their general medical specializations.
Ground Truth Establishment for Test Set: The exact method for establishing ground truth for the 70 TAVR cases is not detailed. The "external cardiologists and radiologists" evaluated the application's performance, but how their evaluations were aggregated or compared against a definitive "ground truth" (e.g., surgical outcome, independent expert consensus) is not described. The statements suggest they evaluated the device's output against their clinical judgment (e.g., "felt that the automated segmentation...enabled an accurate 3D representation").

4. ⁠Adjudication Method for the Test Set

The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for the external validation or for establishing ground truth for the test set.

5. ⁠If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

An MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not described. The external validation involved users (cardiologists and radiologists) evaluating the application, but it doesn't indicate a comparison against a baseline without the software or quantifies an improvement in human reader performance.

6. ⁠If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "automated segmentation" and "automated oblique" as features of the software. The verification testing involved "applying risk management," "performance testing (Verification)," and "safety testing (Verification)," which implies testing of the algorithm's functions. Measurement accuracy tests using phantoms would also be a standalone assessment of the algorithm's precision.
However, the overall validation described (internal and external) focuses on the user's interaction with and ability to verify/adjust the software's outputs, indicating a human-in-the-loop context. No specific "standalone performance study" with metrics like sensitivity, specificity, or accuracy for the algorithm in isolation (without user intervention/correction) is explicitly reported.

7. ⁠The Type of Ground Truth Used

For Measurement Accuracy: Known positions, distances, and angles from imaging phantoms were used as the ground truth.
For External Validation (70 TAVR cases): Not explicitly stated. The document implies a qualitative assessment by "external cardiologists and radiologists" who "felt" the segmentation and oblique were accurate and "were able to" perform their tasks. This suggests a form of expert subjective evaluation rather than a direct comparison against a definitive objective ground truth like pathology, surgical outcomes, or a pre-established consensus gold standard.

8. ⁠The Sample Size for the Training Set

The document does not provide the sample size used for the training set for the Vitrea CT TAVR Planning application. The focus is on validation against the predicate device and usability.

9. ⁠How the Ground Truth for the Training Set Was Established

Since the training set size is not mentioned, the method for establishing its ground truth is also not described in the provided document. The 510(k) summary focuses on validating the device for regulatory clearance, primarily through demonstrating substantial equivalence and usability, rather than detailing the underlying machine learning model development.

Summary

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K122578

510(k) Summarv

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.

Purpose of	Vital Images, Inc. hereby submits this traditional 510(k) to providenotification submission of our new Vitrea CT Transcatheter Aortic ValveReplacement (TAVR) Planning application within our already clearedVitrea platform.
Submission:

Submitter: Vital Images, Inc. 5850 Opus Parkway Suite 300 Minnetonka, MN 55343-4414

2134213 Establishment Registration:

Contact Person: lan Nemerov Vice President, General Counsel and Secretary Phone : 952 - 487 - 9622 Fax: 952 - 487 - 9510 E-mail: inemerov@vitalimages.com

510(k) Type: Traditional

Summary Date: August 21, 2012

Device Name

Trade Name: Vitrea CT Transcatheter Aortic Valve Replacement Planning Picture Archiving and Communications System Common Name: Classification Name: System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ)

Predicate Device: Pie Medical Imaging B.V., 3mensio Workstation (K120367)

Device Description:

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive postprocessing application designed to assist medical professionals with the assessment of the aortic root and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.

Intended Use / Indications for Use:

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Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as:

The software processes CT (computed tomography) image data to provide 3D segmentation of . heart structures and vessels relevant to approach planning.
. The user can review the 2D and 3D images to select and plan the delivery path.
The user can determine C-arm angles for use during the procedure. .
The user can verify and adjust the results of segmentation and cross-section measurements. ●
The software provides visualization techniques such as volume rendering, MIP, MPR and . curved MPR.
. The user can identify and edit contours and the centerline automatically or manually.
The user can generate a report with relevant approach planning data and measurements for ● device sizing.
. The software can provide visualization of calcium.
. The user can generate tortuosity calculations along a centerline.

Technological Characteristics Comparison with the Predicate Device:

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a noninvasive post-processing application for the Vitrea platform to assist medical professionals with the assessment of the aortic root and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures.

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning leverages the basic functionality and technology of the existing 510(k) cleared Vitrea platform (K071331). It is an advanced application that extends the functionality of the platform for specific uses. The intended use of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning (to assist medical professionals with the assessment of the aortic valve and in pre-operational planning and post-operative evaluation of transcatheter aortic valve replacement procedures) is substantially equivalent to the cleared intended use of Pie Medical Imaging B.V. 3mensio Workstation [K120367] (assessment of structures of the heart and vessels for pre-operational planning and sizing for cardiovascular interventions and surgerv).

The below technological comparison table shows the equivalence between Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning and the predicate device.

Vitrea CT Transcatheter Aortic ValveReplacement (TAVR) Planning(Submission Subject)	Pie Medical Imaging B.V.,3mensio Workstation (K120367)(Predicate Device)	NotedDifferences
Target Population:
It is intended for a patient who is a candidatefor an Aortic Valve (AV) replacementthrough TAVR procedures.The software enables assessment andmeasurement of aortic valve and relatedventricles. It provides simple techniques toassess the feasibility of a trans-apical, iliac(transfemoral), or subclavian approach tostructures for replacement or repairprocedures.	Same3mensio Structural Heart enablesassessment and measurement of differentstructures of the heart, e.g. aortic valve,mitral valve, and ventricles. It providessimple techniques to assess the feasibility ofa trans-apical, transfemoral (iliac), orsubclavian approach to structures forreplacement or repair procedures.	None



Vitrea CT Transcatheter Aortic ValveReplacement (TAVR) Planning	Pie Medical Imaging B.V.,3mensio Workstation (K120367)	NotedDifferences
(Submission Subject)	(Predicate Device)
Intended Users:
The software allows cardiologists,radiologists and clinical specialists to selectpatient CT studies from various datasources, view them, and process the imageswith the help of a comprehensive set oftools. It provides assessment andmeasurement of different structures of theheart and vessels relevant to approachplanning.	Same3mensio Workstation is a software solutionthat is intended to provide cardiologists,radiologists and clinical specialists additionalinformation to aid them in reading andinterpreting DICOM-compliant medicalimages of structures of the heart andvessels.	None
Anatomical Sites:
The software enables assessment andmeasurement of aortic valve and relatedventricles. It provides simple techniques toassess the feasibility of a trans-apical, iliac(transfemoral), or subclavian approach tostructures for replacement or repairprocedures.	Same3mensio Structural Heart enablesassessment and measurement of differentstructures of the Heart, e.g. aortic valve,mitral valve, and ventricles. It providessimple techniques to assess the feasibility ofa trans-apical, transfemoral or subclavianapproach to structures for replacement orrepair procedures.	None
Where Used (Hospital, Home, Ambulance, etc.)
Hospital	Hospital	None
Human Factors
The software is designed for use on aradiology workstation.	The software is designed for use on aradiology workstation.	None
Use of Contrast
The software requires contrast enhancedCTA images.	The software requires contrast enhancedCTA images.	None
DICOM Standard Compliance:
The software processes DICOM-compliantCT image data.	Same3mensio Workstation software processesDICOM-compliant CT image data.	None
Vitrea CT Transcatheter Aortic ValveReplacement (TAVR) Planning(Submission Subject)	Pie Medical Imaging B.V.,3mensio Workstation (K120367)(Predicate Device)	NotedDifference
Image Processing:
Segmentation:The software provides segmentation, whichcan be manually adjusted, of the ascendingaorta for aortic root measurement.	Same3mensio Structural Heart's Aortic Rootanalysis tool provides segmentation, whichcan be manually adjusted, of the ascendingaorta for aortic root measurements.	None
Centerline:The software's vessel analysis tool providesa centerline, which can be manuallyadjusted, of the vessels relevant totreatment planning.	Same3mensio Workstation provides a centerlinedetection of vessels, which can be manuallyadjusted.	None
Image Display:
The software provides an option to displayvascular anatomy in stretched MPR,orthogonal, multi-dimensional, curved MPR,oblique, MIP, and MinIP views.	Same3mensio Workstation provides manyvisualization and image reconstructiontechniques which also include stretchedMPR, orthogonal, multi-dimensional, curvedMPR, oblique, MIP, and MinIP views.	None
The software provides a 3D view.	Same3mensio Workstation provides a 3D view.	None
Image Assessment:
C-arm Angles:The software provides C-arm angles, whichcan be utilized to determine the bestapproach to access the anatomy during thesurgery.	Same3mensio Workstation provides C-armangulation calculations, which can beutilized to determine the best approach toaccess the anatomy during the surgery.	None
Tools:	Same	None
The software provides tools to measureangle, minimum diameter, length, and areaparameters for device sizing and approachplanning.	3mensio Workstation provides tools tomeasure angle, diameter, length, and areaparameters for device sizing and approachplanning.
Calcification:The software can visualize calcium in theaortic root during iliac (transfemoral) accessapproach, by using existing Vitrea platformfunctionality.	Same3mensio Workstation provides stretchedview option to visualize calcification duringtransfemoral approach.	None
Vitrea CT Transcatheter Aortic ValveReplacement (TAVR) Planning(Submission Subject)	Pie Medical Imaging B.V.,3mensio Workstation (K120367)(Predicate Device)	NotedDifferences
Stenosis:	Same3mensio Workstation enables user to	None
The software enables user to visualize andassess of stenosis by using existing Vitreaplatform's Vessel Probe functionality(K071331).	visualize and assess of stenosis.
Aneurysms:	Same	None
The software enables user to visualize andassess of aneurysms by using existingVitrea platform's Vessel Probe functionality(K071331).	3mensio Workstation enables user tovisualize and assess of aneurysms.
Annulus Plane:	Same	None
The software provides tools for determiningand manually adjusting the annulus valveplane.	3mensio Workstation Structural Heartmodule's Aortic Root feature provides AorticRoot Analysis tool to determine andmanually adjust the annulus plane.
Approach Planning:	Same	None
The software provides procedure tocomplete following approach planning:Iliac (transfemoral) access	3mensio Workstation structure heartmodule's aortic root feature providesfollowing approach planning:
●Subclavian accessTrans-apical planning●	Transfemoral approach, which talksabout iliac accessSubclavian approachApex approach, which talks about●Trans-apical approach planning

Distribute Findings:
The software provides tools to generatereports to distribute findings.	Same	None
	3mensio Workstation provides reportingtools to distribute findings.

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Summary of Non-Clinical Tests:

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning was designed, and tested according to written procedures that included applying risk management. Testing included verification, validation, and evaluation of previously acquired medical images.

The following quality assurance measures were applied to the development of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning:

Risk analysis .
. Requirements reviews
Design reviews t
Performance testing (Verification)
Safety testing (Verification) ●
. Simulated use testing (Validation)

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Verification:

The software verification team had a primary goal of assuring that software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Validation:

The software validation team had a primary goal of assuring that software conforms to user needs and intended uses. The result of the validation team's efforts was evidence, produced by workflow testing, that system requirements and features were implemented, reviewed and met.

Internal Validation:

The software validation team provided internal validation of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning. Internal validation included internal beta testing and internal user acceptance testing.

External Validation:

During external validation of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning, external cardiologists and radiologists evaluated 70 TAVR cases. Each user felt that the automated segmentation within the application enabled an accurate 3D representation of the relevant anatomy. The users also felt the automated oblique provided an accurate starting point for determining the annulus valve plane. All of the users were able to review the 2D and 3D images, verify and correct the results of segmentations and initialization, create measurements, and generate reports.

The software was designed, developed and tested according to written procedures. Software testing was completed to ensure the new feature operates according to its requirements and without impact to existing functionality.

Summary of Clinical Tests:

The subject of this traditional 510(k) notification, Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning, did not require clinical studies to support safety and effectiveness of the software.

Cyber and Information Security:

Confidentiality .
Vitrea platform relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.
Integrity .
Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. Vitrea platform identifies the data it produces, marking and encoding the appropriate DICOM fields.
. Availability
Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
. Accountability
Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.

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Measurement Accuracy:

Measurements and orientations in Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning were verified using various imaging phantoms. These imaging phantoms contain markers at known positions, distances, and angles from one another. The known positions, distances, and angles were used as input into expected results for verification tests that verified the spatial accuracy of image rendering of 2D and 3D images, the accuracy of distance, angular measurement, and navigational tools, as well as the accuracy of orientation markers within Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning.

Performance Standard:

No applicable mandatory performance standards or special controls exist for this device.

Substantial Equivalence:

The intended use and technological characteristics of Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning are substantially equivalent to the intended use and technological characteristics of the predicate device.

Conclusion:

The testing reported in this 510(k) establishes that Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is substantial equivalent to the predicate device and is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a double-stranded snake winding around a staff.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2013

Vital Images, Inc. % Mr. Ian Nemerov Vice President, General Counsel & Secretary 5850 Opus Parkway, Suite #300 MINNETONKA MN 55343

Re: K122578

Trade/Device Name: Vitrea CT Transcatheter Aortic Valvue Replacement (TAVR) Planning Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 21, 2013 Received: January 22, 2013 ·

Dear Mr. Nemerov:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FDA

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122578

Device Name: Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

Indications for Use:

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning includes general functionality such as:

. The software processes CT (computed tomography) image data to provide 3D segmentation of heart structures and vessels relevant to approach planning.
The user can review the 2D and 3D images to select and plan the delivery path. .
The user can determine C-arm angles for use during the procedure. ●
The user can verify and adjust the results of segmentation and cross-section measurements. .
The software provides visualization techniques such as volume rendering, MIP, MPR and curved . MPR.
. The user can identify and edit contours and the centerline automatically or manually.
The user can generate a report with relevant approach planning data and measurements for device . sizing.
The software can provide visualization of calcium. ●
. The user can generate tortuosity calculations along a centerline.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

FDA

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

Page 1 of 1

510 (k) K122578

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).