The TraumaCad Mobile Release 2.0 program is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.

Device Description

TraumaCad Mobile Release 2.0 allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Mobile Release 2.0 supports DICOM and enables the importing and exporting of image files from a central PACS system, or Quentry (Class I device registered by Brainlab AG in the FDA). TraumaCad Mobile Release 2.0 is the web based version of the predicate device TraumaCad 2.0 (cleared by the FDA on March 19, 2008). The TraumaCad Mobile Release 2.0 has the same basic functionality as the predicate device, but is now available as a web based version on additional platforms. TraumaCad Mobile Release 2.0 is a web based device that can be used on PCs, Mac, or iPad 3, 4 or 5 (Air) and interacts with a PACS system or Quentry. No installation is required. TraumaCad Mobile Release 2.0 provides web based access and should only be used on computers and iPads that are already qualified for wireless use in a clinical setting. TraumaCad Mobile Release 2.0 is not intended for use on mobile phones. Use of TraumaCad Mobile Release 2.0 for planning on a tablet is not to replace planning on a workstation. Use on a tablet is only for situations when a workstation is not available.

AI/ML Overview

This document, a 510(k) summary for TraumaCad Mobile Release 2.0, provides information on comparative testing but does not explicitly define acceptance criteria for performance metrics or present a formal study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests.

Here's a breakdown of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify formal "acceptance criteria" with quantitative thresholds (e.g., minimum accuracy, maximum error). Instead, it states that "the test shows that the predicate device TraumaCad 2.0 and TraumaCad Mobile have the same expected results in all of the tests" when comparing marker detection, calibration results, and template positioning. This implies an internal acceptance criterion of equivalence to the predicate device.

Parameter/Character Tested	Acceptance Criteria (Implied)	Reported Device Performance
Marker detection	Same expected results as predicate device TraumaCad 2.0	Achieved same expected results as predicate device TraumaCad 2.0
Calibration result	Same expected results as predicate device TraumaCad 2.0	Achieved same expected results as predicate device TraumaCad 2.0
Templates positioning	Same expected results as predicate device TraumaCad 2.0	Achieved same expected results as predicate device TraumaCad 2.0
Usability	Simulated clinical environment, pre-operative planning, and functional testing demonstrates satisfactory performance	Testing performed on Hip and Knee procedures; primary operating functions tested in a clinical environment; most participants familiar with predicate device workflow. Implied satisfactory usability.
Non-clinical testing	Safety and effectiveness demonstrated for defined indications of use, performs as well as or better than predicate device	Successful non-clinical testing demonstrates safety and effectiveness and performance as well as or better than the legally marketed predicate device.

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

Test Set Sample Size: The document repeatedly mentions "various medical images from a range of cases," "various Hip X-rays," and "various knee images." However, no specific numerical sample size for the test set is provided.
Data Provenance: The images are described as "pre-obtained digital images via PACS system or via Quentry." This suggests retrospective data collected from typical clinical archives. There is no information about the country of origin of the data.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The tests involved comparing the subject device's results to those of the predicate device (TraumaCad 2.0), implying the predicate device's output or methods serve as a form of reference, but not explicitly a human-established ground truth for each case.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The testing involved "comparing TraumaCad 2.0 on a PC device and TraumaCad Mobile on an iPad device," suggesting a direct comparison of outputs rather than an independent expert adjudication process for each case.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

No MRMC comparative effectiveness study is reported. The focus is on the device's functional equivalence to the predicate, not on how human readers' performance improves with or without the AI assistance of TraumaCad Mobile.

6. Standalone (Algorithm Only) Performance Study

The reported testing focuses on the device's functionality, including "Marker detection, Calibration result and Templates positioning," and compares these directly to the predicate device's performance. This implies a form of standalone performance evaluation in the sense that the device's algorithms are being assessed for their output equivalence to an established system without necessarily involving human interpretation as the primary outcome being measured. The product is described as "assisting healthcare professionals," so while the tests evaluate the algorithm's output, it's within the context of a human-in-the-loop workflow.

7. Type of Ground Truth Used

The "ground truth" implicitly used for the functional tests such as marker detection, calibration, and template positioning is the output generated by the predicate device, TraumaCad 2.0. For usability, the "ground truth" would be the successful completion of tasks and overall user satisfaction, observed during the simulated clinical environment testing. There is no mention of pathology or outcomes data being used as ground truth for these specific tests.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. It mentions that "The algorithms contained on TraumaCad Mobile are the same as those that are in the predicate device TraumaCad 2.0 that have been extensively tested," suggesting that the underlying algorithms were developed and likely trained prior to this specific device iteration, possibly with data associated with TraumaCad 2.0.

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

Since no specific training set information is provided, how the ground truth for an (unspecified) training set was established is not detailed. The statement about the algorithms being the same as in the predicate device (TraumaCad 2.0) suggests that any previous ground truth establishment for those algorithms would have occurred during the development and testing of TraumaCad 2.0.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

February 12, 2016

Voyant Health, Ltd. % Mr. Yael Guttentag QM&RA Manager 35 Efal Street Petach-Tikva 4951132 ISRAEL

Re: K160001

Trade/Device Name: Traumacad Mobile Release 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 25, 2016 Received: January 29, 2016

Dear Mr. Guttentag:

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, listing 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160001

Device Name TraumaCad Mobile Release 2.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for "Voyant HEALTH". The logo features a stylized flower-like graphic on the left, with petals in green, gray, and orange. To the right of the graphic is the word "Voyant" in blue, followed by "HEALTH" in green. There is a trademark symbol after the word "HEALTH".

vant Health Ltd h-Tikva, 4951132

ww.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. Submitter's Yael Guttentag Address: Voyant Health, Ltd. (a) 35 Efal Street Petach-Tikva Israel, 4951132
1. Manufacturer Voyant Health, Ltd. (b) Address: 35 Efal Street Petach-Tikva Israel, 4951132
- Mfq. Phone: 972-3-929-0929
- Mfg. Fax: 972-3-923-6413
- Contact Yael Guttentag, QM&RA Manager Person:
- Date: Dec 29, 2015
1. Device & Imaging Processing System (Class 2), Product Code LLZ, 21 CFR 892.2050 Classification Name: Trade name of device: TraumaCad Mobile Release 2.0
1. Predicate TraumaCad Release 2.0 (K073714) Device: TraumaCad Mobile Release 1.0 (K142923)
TraumaCad Mobile Release 2.0 allows surgeons to evaluate 4. Description: digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitate the film-less orthopedic practice. The program features full PACS integration and an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Mobile Release 2.0 supports DICOM and enables the importing and exporting of image files

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower with three petals in green, gray, and orange, followed by the word "Voyant" in blue. To the right of "Voyant" is the word "HEALTH" in green, with a trademark symbol next to it.

ovant Health Ltd tal Street tach-Tikva, 4951132

www.voyanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

from a central PACS system, or Quentry (Class I device registered by Brainlab AG in the FDA).

TraumaCad Mobile Release 2.0 has the same intended use as TraumaCad Mobile Release 1.0 (K142923 cleared by the FDA on March 5, 2015) and the same basic features as predicate device TraumaCad Release 2.0 (K073714 cleared by the FDA on March 19, 2008). Three new procedures have been added. Knee, Upper Limb, and Foot&Ankle to the predicate device TraumaCad Mobile Release 1.0. These procedures exist in the predicate device TraumaCad 2.0. This allows pre-operative planning in these areas, as well as the previously cleared Hip procedure. In addition, TraumaCad Mobile Release 2.0 has the ability to open more than one image at a time, similar to the predicate device TraumaCad 2.0.

TraumaCad Mobile Release 2.0 is the web based version of the predicate device TraumaCad 2.0 (cleared by the FDA on March 19, 2008). The TraumaCad Mobile Release 2.0 has the same basic functionality as the predicate device, but is now available as a web based version on additional platforms. The differences between the device and the predicate device do not impact on substantial equivalence.

TraumaCad Mobile Release 2.0 is a web based device that can be used on PCs, Mac, or iPad 3, 4 or 5 (Air) and interacts with a PACS system or Quentry. No installation is required. TraumaCad Mobile Release 2.0 provides web based access and should only be used on computers and iPads that are already qualified for wireless use in a clinical setting. TraumaCad Mobile Release 2.0 is not intended for use on mobile phones. Use of TraumaCad Mobile Release 2.0 for planning on a tablet is not to replace planning on a workstation. Use on a tablet is only for situations when a workstation is not available.

In order to access TraumaCad Mobile, the user needs to browse to a specific URL and enter the system via username and password. A Web Application is available in the iTunes store that will automatically open the browser with the correct URL. The application can be downloaded from iTunes for free but cannot be used without receiving a license to ensure the

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower with four petals in different colors: orange, gray, green, and blue. To the right of the flower is the text "Voyant HEALTH" with "Voyant" in blue and "HEALTH" in green. There is a trademark symbol after the word HEALTH.

ch-Tikva, 4951132

ww.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413

use by appropriate healthcare professionals.

The program features full PACS integration and an extensive reqularly updated library of digital templates from leading manufacturers. TraumaCad Mobile Release 2.0 supports DICOM and enables the importing and exporting image files from a central PACS system or from Quentry.

The TraumaCad Mobile Release 2.0 program is indicated for 5. Intended Use: assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
1. Conclusion The successful non-clinical testing demonstrates the safety and effectiveness of the TraumaCad Mobile Release 2.0 when used for the defined indications for use and demonstrates that these devices for which this 510(k) is submitted perform as well as or better than the legally marketed predicate device.

TraumaCad Mobile contains a subset of the features from TraumaCad 2.0. The algorithms contained on TraumaCad Mobile are the same as those that are in the predicate device TraumaCad 2.0 that have been extensively tested.

The testing for each release consisted of Unit, System/Integration and Acceptance test levels. Testing included security, neqative testing, error message handling, stress testing, platform testing, workflow testing, functional testing, multi-user/external access testing, data integrity testing, compatibility testing, load testing, regression testing, and hazard mitigation testing.

In case a test was failed any necessary corrections were made, the relevant test was executed and repeated again until all passed.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like symbol on the left, with three petals in orange, gray, and blue. To the right of the symbol is the text "Voyant" in blue, followed by "HEALTH" in green. A small trademark symbol appears to the upper right of the word HEALTH.

ovant Health Ltd tal Street etach-Tikva, 4951132

ww.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

TraumaCad Mobile Release 2.0 is the same as the TraumaCad 7. Changes to Mobile Release 1.0 with the addition of three new procedures, Predicate Device Knee, Upper Limb, and Foot&Ankle. This allows pre-operative planning in these areas, as well as the previously cleared Hip procedure. These procedures exist already in the predicate device TraumaCad 2.0 and they have been added to the TraumaCad Mobile Release 2.0.
In TraumaCad Mobile Release 1.0 only the Hip procedure was implemented. In TraumaCad Mobile Release 2.0 the following procedures have been added.
Knee Knee procedure is aimed to provide the users . with a method to perform Total Knee Replacement (TKR), including evaluation of resection line, positioning of implant templates and auto alignment, for AP and LAT images.
Foot&Ankle Foot&Ankle procedure allows positioning ● of specific Foot&Ankle implant templates on the image
. Upper Limb – Upper Limb procedure allows positioning of specific Upper Limb implant templates on the image

Multiple Images – In the predicate device TraumaCad Mobile Release 1.0, only one image could be opened at a time. TraumaCad Mobile Release 2.0 supports opening of up to two images. This functionality already exists in the predicate device TraumaCad 2.0, which can open up to 4 images at a time.

1. Comparison of TraumaCad Mobile Release 2.0 has the same intended use Technological and risk control measures as the predicate device TraumaCad Characteristics: Mobile Release 1.0. TraumaCad Mobile Release 2.0 contains a limited feature set in comparison to the predicate device TraumaCad 2.0. The features in TraumaCad Mobile already exist in the predicate device TraumaCad but have been modified to run on new platforms. Thus we revisited our risk analysis to consider any new potential failure modes and causes for hazards intrinsic to the new mobile environment and implemented new risk control measures as necessary.
  Testing was done to compare TraumaCad Mobile with the predicate device TraumaCad 2.0 using various medical images from a range of cases in parallel and comparing TraumaCad 2.0 on a PC device and TraumaCad Mobile on an iPad device. Testing included the main functions such as: Marker detection,

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like symbol on the left, with three petals in green, gray, and orange. To the right of the symbol is the word "Voyant" in blue, followed by "HEALTH" in green. A small trademark symbol is located to the upper right of the word "HEALTH".

vant Health Ltd ch-Tikva, 4951132

ww.vovanthealth.com

Phone: +972-3-929-0929 +972-3-923-6413 Fax:

Calibration result and Templates positioning. The test shows that the predicate device TraumaCad 2.0 and TraumaCad Mobile have the same expected results in all of the tests.

In addition, usability testing was performed using mobile devices and PC environments. The Usability testing simulated a clinical environment and required the test participant to perform preoperative planning on various Hip X-rays in a manner that is almost identical to the planning done on the predicate device. Most of the test participants had used the predicate device TraumaCad 2.0 in the past and were familiar with the workflow in the predicate device.

The primary operating functions (which exist in the predicate device as well) were tested in a clinical environment and include:

Select an x-ray image from Quentry/PACS •
. Calibrate the image
Select implants
. Evaluate LLD and offset changes
Change the implant properties accordingly
. Use measurement tools
. Save the results back to Quentry/PACS

Additional Usability testing was done on the Knee procedure of TraumaCad Mobile Release 2.0 in order to simulate a clinical environment. Various knee images were used and multiple templates placed on the images.

The primary operating functions were tested in a clinical environment and include:

Select the relevant clinical procedure ●
. Calibrate the Knee x-ray image
. Select implants - femoral and tibial components
Change the implant properties
. Evaluate the resection line and mechanical and anatomical axis.
Perform Auto Alignment

Based on the above testing and updated risk analysis, the differences between the device and the predicate devices do not impact on substantial equivalence.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like graphic on the left, with three petals in orange, gray, and blue. To the right of the graphic is the text "Voyant" in blue, followed by "HEALTH" in green, with a trademark symbol.

Voyant Health Ltd. 35 Efal Street Petach-Tikva, 4951132 ISRAEL

www.voyanthealth.com

Phone: +972-3-929-0929
Fax: +972-3-923-6413

Parameter/Character	Subject DeviceTraumaCadMobile 2.0	PredicateDeviceTraumaCadMobile 1.0	PredicateDeviceTraumaCad 2.0
Operating System	MS Windows 7,8 or 10iOS 7.x, 8.x or9.xMac OS X	MS Windows 7iOS 6.1 or 7.xMac OS X	Windows/PCMS Windows2000 or later
Devices supported	PC/MACiPad 3, 4 and 5(Air)	PC/MACiPad 3, 4 and 5(Air)	PC
Browsers supported	Minimumrequirements:iOS basedbrowsers:- Safari 7- Chrome 30Mac basedbrowsers:- Firefox 26- Safari 5Windows basedbrowsers:- Chrome 30- Firefox 26- Safari 5- IE 11	Minimumrequirements:iOS basedbrowsers:- Safari 7- Chrome 30Mac basedbrowsers:- Firefox 26- Safari 5Windows basedbrowsers:- Chrome 30- Firefox 26- Safari 5- IE 11	NA
Image Input	Can receivedigital imagesfrom varioussources	Can receivedigital imagesfrom varioussources	Can receivedigital imagesfrom varioussources
Means of CollectingData	Obtained frompre-obtaineddigital imagesvia PACSsystem or viaQuentry	Obtained frompre-obtaineddigital imagesvia PACSsystem or viaQuentry	Obtained frompre-obtaineddigital imagesvia PACSsystem or viaQuentry
Parameter/Character	Subject DeviceTraumaCadMobile 2.0	PredicateDeviceTraumaCadMobile 1.0	PredicateDeviceTraumaCad 2.0
Number of Imagesthat cansimultaneouslyviewed on screen	Up to Two	One	Up to 4
Runs on Server	Yes	Yes	Yes
Hip Module	Yes	Yes	Yes
Trauma Module	No	No	Yes
Knee Module	Yes	No	Yes
Spinal Module	No	No	Yes
Pediatric Module	No	No	Yes
Foot & Ankle Module	Yes	No	Yes
Upper Limb Module	Yes	No	Yes
Input 3D Images	No	No	Yes
Digital ProstheticTemplates	Yes	Yes	Yes
Interactive templatepositioning	Yes	Yes	Yes
Automatic Scaling	Yes	Yes	Yes
Template supportfrom manufacturers	Yes	Yes	Yes
Permits templaterotation	Yes	Yes	Yes
Pre-operativePlanning	Yes	Yes	Yes
Patient Contacting	No	No	No
Control of Life-SavingDevices	No	No	No
Healthcareprofessionalsintervention forinterpretation andmanipulation ofimages	Yes	Yes	Yes
510(k) #	Pending	K142923	K073714

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Voyant Health. The logo consists of a stylized flower-like graphic on the left, with three petals in orange, gray, and green. To the right of the graphic is the word "Voyant" in blue, followed by the word "HEALTH" in green, with a trademark symbol.

Voyant Health Ltd.
35 Efal Street Petach-Tikva, 4951132 ISRAEL

www.voyanthealth.com

Phone: +972-3-929-0929
Fax: +972-3-923-6413

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).