Corporate Dental Imaging (CDI) Application™ is a software device for general dental diagnostic imaging. It controls capture, display, transfer, enhancement, and storage of X-ray dental images from digital imaging systems.

Device Description

The Corporate Dental Imaging (CDI) Application™ is a software application used for storing and displaying medical dental images. The application conforms to the DICOM 3.x standard to allow interoperability with other DICOM compliant systems. The implementation of CDI interface has been tested to assure compliance with the DICOM Conformance Statement. CDI is comprised of one (1) desktop client for Modality Image Capture, one (1) web-based client for Image Viewing and Diagnostics with Microsoft SQL Server back-end database(s) for storing DICOM images. CDI will capture images directly from intra-oral and extra-oral acquisition modalities, full color images from intra-oral cameras, digital cameras and other video sources. CDI is loaded onto the Acquisition PCs in the clinic where either the images will be acquired or where the images will need to be viewed. CDI will use the hardware vendor's own drivers to seamlessly initialize the acquisition modality from within the CDI UI. CDI will be designed to create a standard DICOM object that conforms to industry standards. CDI will also provide easy-to-use image processing tools that aid providers in analyzing images and making diagnoses. CDI will allow users to enhance the contrast and brightness of an image, reverse image values to show dental caries, and magnify specific areas of concern.

AI/ML Overview

This document is a 510(k) summary for the Corporate Dental Imaging (CDI) Application™. It primarily aims to demonstrate substantial equivalence to a predicate device (XELIS DENTAL, K102684) and does not contain detailed information about acceptance criteria and a study proving the device meets them in the context of diagnostic accuracy or clinical performance.

The provided text focuses on:

Device Description: What the CDI Application is (software for storing and displaying dental X-ray images, DICOM compliant).
Indications for Use: General dental diagnostic imaging, control of capture, display, transfer, enhancement, and storage of X-ray dental images.
Technological Characteristics Comparison with Predicate Device: A table comparing functionalities like computer platform, OS, networking, image compression, image storage, 2D image viewer tools, and specialized dental features.
Nonclinical Testing: Mentions that the device has been "assessed and tested at the factory" and "passed all in-house testing criteria." It also states "Validation testing indicated that... results demonstrated that the predetermined acceptance criteria were met."

However, it does not provide:

A specific table of acceptance criteria with reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision for image analysis tasks).
Details about a study that measures the device's diagnostic performance against such criteria.
Information on sample sizes, ground truth establishment methods (e.g., pathology, expert consensus), or expert qualifications for a diagnostic study.
Any mention of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The "Nonclinical Testing" section refers to "predetermined acceptance criteria" for verification and validation but does not define these criteria or present the results in a way that would allow for a detailed analysis of diagnostic performance. It implies that these tests were related to software functionality and system performance rather than clinical diagnostic efficacy.

Therefore, based solely on the provided document, the requested information regarding acceptance criteria and performance study as typically understood for diagnostic AI/CADe devices cannot be fully detailed.

Here's a summary of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Mentioned (Implicit from "Nonclinical Testing" section):

Device functions as intended (e.g., capture, display, transfer, enhancement, storage of images).
DICOM 3.x standard compliance for interoperability.
Adherence to software requirements and specifications.
Absence of new potential safety risks compared to the predicate.
Operational efficiency for the specified computer platforms and operating systems.
Basic image manipulation tools (pan, zoom, centering, windowing, flip, rotation, layouts, annotation).

Reported Device Performance:
The document states: "Validation testing indicated that... results demonstrated that the predetermined acceptance criteria were met." However, no specific quantitative performance metrics (e.g., error rates, processing speeds, image quality metrics) are provided. The comparison table with the predicate device (XELIS DENTAL) focuses on functionality presence rather than quantitative performance comparison. The key takeaway from the comparison is that the CDI Application™ has reduced functionality compared to the predicate, but these differences "do not create new risks and do not impact safety or efficacy" and are not required for its intended use.

2. Sample size used for the test set and the data provenance

Not provided. The document refers to "in-house testing criteria" and "Validation Test Plan" but does not specify the number of images or cases used in any testing, nor their origin (e.g., country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. The document focuses on software functionality and substantial equivalence to a predicate PACS system, not on a diagnostic performance claim that would typically require expert-established ground truth for a test set. There's no mention of experts or their qualifications in the context of evaluation.

4. Adjudication method for the test set

Not applicable/Not provided. As no diagnostic performance study is detailed, no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document does not describe any MRMC study or any study involving human readers' performance with or without AI assistance. The device is described as a Picture Archiving and Communications System (PACS) with basic image manipulation tools, not an AI/CADe diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. The device is a software application for image handling and display, not a standalone diagnostic algorithm. The document explicitly states: "The subject device does not include any automated or semi-automated processes for the detection of nodules or other shapes." and "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and or printed."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. As this is a PACS system without automated diagnostic capabilities, a ground truth in the sense of disease presence/absence is not discussed for its evaluation. Its evaluation focuses on functional performance and adherence to standards.

8. The sample size for the training set

Not applicable/Not provided. The device described is a software application (PACS) for image management and display, not a machine learning or AI algorithm that would typically require a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. As stated above, this is not an AI/ML device requiring a training set.

Summary

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

August 19, 2015

U.S. Army Dental Command (DENCOM) % Mr. Carl Alletto Consultant OTech, Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K151371

Trade/Device Name: Corporate Dental Imaging (CDI) Application"*** Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 29, 2015 Received: August 4, 2015

Dear Mr. Alletto:

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.

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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 O'Hara

For

Robert Ochs, Ph.D. Acting 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)

K151371

Device Name Corporate Dental Imaging (CDI) Application™

Indications for Use (Describe)

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)

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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

May 5, 2015

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. William K. Porter Chief Operating Officer (COO) Information Management and Technology Division (IMTD) U.S. Army Dental Command (DENCOM) 4270 Gorges Circle Suits 101, B1070 Fort Sam Houston, Texas 78234 Tel: 210 808-2748 Fax: 210 295-3013 Email: William.k.porter.civ@mail.mil

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Product Name:	Corporate Dental Imaging (CDI) Application™
Common Name:	Picture, archive and communications system
Classification Name:	System, Image Processing, Radiological
Product Code:	LLZ

Predicate Device: 21 CFR 807. 92(a)(3)

The Corporate Dental Imaging (CDI) Application™ system is substantially equivalent to:

Device Classification Name	system, image processing, radiological
510(k) Number	K102684
Device Name	XELIS DENTAL
Original Applicant	INFINITT CO., LTD.12f Daerung Post Tower III182-4 Guro-Dong, Guro-GuSeoul, KR 152-050
Regulation Number	892.2050
Classification Product Code	LLZ
Date Received	09/17/2010
Decision Date	10/01/2010
Regulation Medical Specialty	Radiology
510k Review Panel	Radiology

Device Description: 21 CFR 807 92(a)(4)

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suite and to validate the required interoperability. A network environment may need additional functions out of the scope of DICOM.

Note: The subject device does not include any automated or semi-automated processes for the detection of nodules or other shapes.

The Corporate Dental Imaging (CDI) Application ™ system is being designed as a replacement for the legacy PACS system known as DEVAA. CDI will replace the legacy PACS technologies found in DEVAA with a more robust software and hardware solution. In addition, CDI will add additional capabilities not available in legacy capture/view tools. Additional benefits include providing a global view of images through DICOM image data query across multiple service image archives and the capability to migrate existing DICOM images to new image servers. In addition, CDI offers the capability to query and retrieve images at any location within the digital enterprise for primary, ghosted and retake images.

CDI is comprised of one (1) desktop client for Modality Image Capture, one (1) web-based client for Image Viewing and Diagnostics with Microsoft SQL Server back-end database(s) for storing DICOM images. There is at least one instance of this environment. Each Military clinical post will most likely have multiple instances of this environment depending upon the volume of productivity. CDI will form the core of the acquisition and viewing operations within the enterprise architecture. CDI will capture images directly from intra-oral and extra-oral acquisition modalities, full color images from intra-oral cameras, digital cameras and other video sources. CDI is loaded onto the Acquisition PCs in the clinic where either the images will be acquired or where the images will need to be viewed. If the PC is being used to acquire images, CDI is configured to use the attached acquisition modalities. CDI is has been designed to be able to acquire an image regardless of the acquisition modality used to capture the image. CDI will use the hardware vendor's own drivers to seamlessly initialize the acquisition modality from within the CDI UI. It does not matter which type of modality is used to acquire the image, or which type of image series that might be taken, the user is always presented with the same interface. CDI will be designed to create a standard DICOM object that conforms to industry standards. The use of DICOM is an absolute necessity to ensure interoperability with current and future imaging systems. CDI will also provide easy-touse image processing tools that aid providers in analyzing images and making diagnoses. CDI will allow users to enhance the contrast and brightness of an image, reverse image values to show dental caries, and magnify specific areas of concern.

Note: Modifications can be saved, but they are only saved as a copy of the original image. The original image will always remain untouched.

Indications for Use: 21 CFR 807 92(a)(5)

Technological Characteristics: 21 CFR 807 92(a)(6)

Corporate Dental Imaging (CDI) Application™ is a software device that handles and manipulates digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and or printed. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS; this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The subject device and predicate device are substantially equivalent in the areas of technical

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510(k) Summary of Safety

characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The predicate and subject devices are substantially equivalent in the areas of general function, application, and intended use. Any difference between the two devices does not affect safety or efficacy. The predicate device and the new device are compared below:

Functionality	Predicate:XelisDENTAL(K102684)	SubjectDevice: CDIApplication™	If different, Impact on Safety and orEfficacy
Computer platform (minimumrequirements)	IBMcompatibleMemory:1GBDisk: 200MBfree harddisk space	IBMcompatibleCPU: 1 DualCoreProcessorMemory: 8GBRAMHDD: C:(OS)=140GB;D: (Data)=2TB	Yes, there are differences.Current computer platforms have theseadded hardware features to support theoperating system, Microsoft Windows 64bit 2008 R2 Enterprise, and they are forthe operating system to run efficiently.The difference does not create new risksand does not impact safety or efficacy asexplained in rationale below section 6.1.1(a) below
Computer Operating System	MicrosoftWindowsXP/Vista orhigher (32bit& 64 bit)Professional	MicrosoftWindows 64 bit2008 R2Enterprise	Yes, there are differences.The Windows XP and Vista is no longersupported by Microsoft. CDI uses theMicrosoft Windows 64 bit 2008 R2Enterprise operating system. The systemhas passed testing against pre-determined criteria and the differencedoes not create new risks and does notimpact safety or efficacy.
Enterprise distribution ofimages and data via Internetor Intranet	Yes	Yes	No differences
Networking CommunicationsProtocol - DICOM 3.x	Yes	Yes	No differences
Image Compression:	Nocompressionor Lossless	Nocompressionor Lossless	No differences
Standard Interfaces -Ethernet	Yes	Yes	No differences
Image Storage- Server & onboard hard disk size &compression dependent. Canstore to Short or Long TermArchives	Yes	Yes	No differences
Multi-Planar Reformation(MPR) - MPR into any classicplanes (axial, sagittal,coronal, oblique planes) andcurved and free-draw planarreformation. 3D image-guidedreformation on VR, MIP/MinIP	Yes	No	Yes, there are differences.MPR is not a feature that is implementedin the Medical Viewer and there are noclaims as such in the CDI device labeling.This feature is not required to meet thesubject device intended use. The systemhas been tested against pre-determinedcriteria and passed. The difference doesnot create new risks and does not impactsafety or efficacy.
Virtual Endoscopy - Observethe internal structure usingthe virtual camera.	Yes	No	Virtual Endoscopy is not a feature that isimplemented in the CDI and there are noclaims in the CDI device labeling for this
Functionality	Predicate:XelisDENTAL(K102684)	SubjectDevice: CDIApplication™	If different, Impact on Safety and orEfficacy
Reporting - Save, email,DICOM send, or print tostandard Windows printers	Yes	No	Yes, there are differences.Reporting - Save, email, DICOM send, orprint to standard Windows printers is not afeature implemented in CDI and there areno claims in the CDI device labeling forthis feature. This feature is not required tomeet the subject device intended use. Thesystem has been tested against pre-determined criteria and passed. Thedifference does not create new risks anddoes not impact safety or efficacy.
Move, rotate, flip and deletetemplate	Yes	Rotate and flipimages only	Yes there are differences.The CDI application itself cannot move ordelete images. This feature is not requiredto meet the subject device intended use.The system has been tested against pre-determined criteria and passed. Thedifference does not create new risks anddoes not impact safety or efficacy.
Draw line	Yes	Yes	No differences
Draw arrow	Yes	Yes	No differences
Write text	Yes	Yes	No differences
Measure distance	Yes	No	Yes, there are differences.Measurement is not a feature in the CDIapplication. This feature is not required tomeet the subject device intended use. Thesystem has been tested against pre-determined criteria and passed. Thedifference does not create new risks anddoes not impact safety or efficacy.
Measure angle	Yes	Yes	No differences
Measure area	Yes	Yes	No differences
Print image	Yes	Yes	No differences
2D Image Viewer- 2D imageviewer with real-time pan,zoom, centering, windowing,flip, rotation, free layouts, cineand annotation Tools forremoval of obscuringanatomy including ROIdrawing, ROI dilation anderosion, paint, fence,thresholding, 2D & 3D regiongrowing and balloon.Analytical tools for measuringdistance, angle, ROI, grid,table, profile, time-densitycurve, pixel coordinate, andscale bar.	Yes	2D imageviewer - 2Dimage viewerhas thefollowing: real-time pan,zoom,centering,windowing, flip,rotation, freelayouts andannotationTools.	Yes there are differences in the CDIapplication which has reducedfunctionality compared to the predicatedevice. However, these features are notrequired to meet the subject deviceintended use. The system has beentested against pre-determined criteria andpassed. The difference does not createnew risks and does not impact safety orefficacy.
MIP/MinIP - maximumintensity projection	Yes	No	Yes there are differences in the CDIapplication which has reduced
Functionality	Predicate:XelisDENTAL(K102684)	SubjectDevice: CDIApplication™	If different, Impact on Safety and orEfficacy
			functionality compared to the predicatedevice. However, this feature is notrequired to meet the subject deviceintended use. The system has beentested against pre-determined criteria andpassed. The difference does not createnew risks and does not impact safety orefficacy.
Dental volume reformatfunctions, such as arch/curve,drawing nerve-canal, axis andre-slice based on dental arch	Yes	No	Yes there are differences in the CDIapplication which has reducedfunctionality compared to the predicatedevice. However, this feature is notrequired to meet the subject deviceintended use. The system has beentested against pre-determined criteria andpassed. The difference does not createnew risks and does not impact safety orefficacy.
Dental implant planning,which provides simulations ofimplant placement, bone-structure analysis andlocation of the mandibularcanal.	Yes	No	Yes there is a difference. This is not afeature in the CDI application. A featurefor simulations of implant placement,bone-structure analysis and location of themandibular canal is not implemented orclaimed. This feature is not required tomeet the subject device intended use. Thesystem has been tested against pre-determined criteria and passed. Thedifference does not create new risks anddoes not impact safety or efficacy.
Intended Use1	Picturearchivingandcommunicationon systems(PACS)	Picturearchiving andcommunicationsystems(PACS)	Yes, there are differences but bothsystems are a picture archiving andcommunication systems (PACS) is acombination of hardware and softwarededicated to the short and long termstorage, retrieval, management,distribution, and presentation of images.Electronic images and reports aretransmitted digitally via PACS; thiseliminates the need to manually file,retrieve, or transport film jackets. Theuniversal format for PACS image storageand transfer is DICOM (Digital Imagingand Communications in Medicine). Thereare differences in the features andfunctions used in the subject device whencompared to the predicate.The subject device has less features.However, the features and functions thatare no in the subject device are not
Functionality	Predicate:XelisDENTAL(K102684)	SubjectDevice: CDIApplicationTM	If different, Impact on Safety and orEfficacy
			required to meet the subject deviceintended use. The system has beentested against pre-determined criteria andpassed. The difference does not createnew risks and does not impact safety orefficacy.

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1 "Intended Use" is the "Objective Intent" for the device of the persons legally responsible for labeling the device. The FDA defines "Intended Use" as: The term "intended uses" refers to the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. It may be shown by the offering or the device, with the knowledge of such persons or their representatives, for a purpose for which it is neither labeled nor advertised. (21 CFR 801.4)

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Nonclinical Testing:

The Corporate Dental Imaging (CDI) Application™ device has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification & Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the Corporate Dental Imaging (CDI) Application™ software in each operational mode and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by the manufacturer, integration and installations verification tests will be conducted against acceptance criteria prior to being released to the user facility.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the Corporate Dental Imaging (CDI) Application™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of general function, application, and intended use. The subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Nonclinical tests demonstrate that the device is safe and effective for its' intended use. Therefore, the Corporate Dental Imaging (CDI) Application™ is substantially equivalent to the predicate device.

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).