The Volume Viewing software is a visualization package for PACS workstations. It is intended to support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital image processing tool, with optional functionality to facilitate visualization and measurement of vessel features.

Other optional functionality is intended for the registration of anatomical (CT) on a second CT dataset or on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumour measurements, and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI), has a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and provides tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline.

Caution: Web-browser access is available for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.

Device Description

IMPAX Volume Viewing is a general purpose medical image processing tool for the reading and analysis of 3D image datasets. It is also intended for the registration of anatomical (CT) image data onto functional (MR) data to facilitate the comparison of various lesions. Volume and distance measurements facilitate the quantification of lesions and the analysis of both soft and hard tissue.

A variant of the software also provides web-browser access for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.

The new device is similar to the predicate devices. All are PACS system accessories that allow the user to view and manipulate 3D image data sets. This new version adds a dedicated tool set for lesion management and flythrough visualizations rendered along a centerline for endoscopic view of vessels and airways.

Principles of operation and technological characteristics of the new and predicate devices are the same.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the IMPAX Volume Viewing 4.0 system.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Aspect	Acceptance Criteria	Reported Device Performance
Measurement Accuracy (diameters, areas, volumes)	+/- scanner resolution (for dataset uncertainty)	Results met the established acceptance criteria of +/- scanner resolution (for dataset uncertainty).
Crosshair Position Checks (viewport linking)	Half a voxel (for rounding differences across graphic video cards)	Results met the established acceptance criteria of half a voxel (for rounding differences across graphic video cards).
New Functionality Evaluation (Endoscopic Viewing, Lung Nodule Segmentation, Lesion Management Module)	Clinical utility and performance deemed adequate by experts. Substantially equivalent to predicate devices.	Endoscopic viewing of tubular structures (vessels and airways): Found to be substantially equivalent to the predicate iNtuition 4.4.11. Accuracy of lung nodule segmentation and capabilities of the lesion management module: Found to be adequate to segment lesions, analyze them, and follow-up on their growth over time.
General Performance, Safety, Usability, Security	Meets requirements established by in-house SOPs conforming to various ISO and IEC standards.	Verification and validation testing confirmed the device meets performance, safety, usability, and security requirements. (Specific metrics for these are not detailed beyond "met requirements" but implicitly covered by the standards listed: ISO 13485, ISO 14971, ISO 27001, ISO 62366, IEC 62304).

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

Sample Size: The document states that "representative clinical datasets" were selected and loaded by the radiologists. The exact number of cases/datasets in the test set is not specified.
Data Provenance: The radiologists were invited to Agfa's facilities, implying the clinical datasets were likely from retrospective cases, although this is not explicitly stated. The country of origin of the data is not specified but given the location of the testing (Belgium), it is plausible the data also originated from Belgium or nearby European countries.

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

Number of Experts: 3 radiologists
Qualifications of Experts: The document states "3 radiologists from several Belgian hospitals." Specific years of experience or subspecialty certification (e.g., neuroradiologist, interventional radiologist) are not provided.

4. Adjudication method for the test set:

The document states that the radiologists "executed typical workflows and scored the features under investigation. A scoring scale was implemented and acceptance criteria established." This implies a consensus-based scoring or independent scoring followed by a determination of whether acceptance criteria were met. An explicit adjudication method like "2+1" or "3+1" is not 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, an MRMC comparative effectiveness study was not done. The study involved radiologists evaluating the functionality of the device, rather than comparing human reader performance with and without AI assistance on specific diagnostic tasks. The focus was on demonstrating the functionality and subjective adequacy of the new features and equivalence to predicate devices, not on improving human reader performance. This device is primarily a visualization and processing tool, not an AI-powered diagnostic aid that would typically be evaluated in an MRMC study for reader improvement.

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

Yes, in part. The "Verification" section describes tests on the algorithms themselves:
- Regression testing on measurement algorithms to ensure they provide the same output as the previous version.
- Crosshair position checks to verify viewport linking.
- The "accuracy of the lung nodule segmentation" was scored, suggesting a standalone performance aspect of this algorithm was evaluated against some reference.
The "Validation" section involved human readers evaluating the new functionality, but the underlying measurements and segmentations are performed by the algorithms. So, the algorithms' standalone performance was assessed for accuracy and functionality, and then confirmed by human interaction during validation.

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

For Measurement Accuracy: "Reference values" were used, which implies a pre-established, highly accurate measurement for the specific datasets (e.g., from a precisely measured phantom or a highly accurate prior measurement). The exact nature of these reference values is not explicitly stated.
For Crosshair Position Checks: The ground truth was based on expected precise pixel/voxel alignment ("half a voxel").
For New Functionality (Endoscopic Viewing, Lung Nodule Segmentation, Lesion Management Module): The ground truth was expert evaluation/consensus by the 3 radiologists regarding the adequacy and equivalence of the functionality.

8. The sample size for the training set:

The document does not provide any information about a training set. This device is presented more as an advanced image processing and visualization tool rather than a machine learning/AI diagnostic algorithm that typically requires a large training set. While some algorithms (like segmentation) may inherently involve learned parameters, no details on their training are given.

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

As no information on a training set is provided, the method for establishing its ground truth is also not specified.

Summary

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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 a caduceus, which is a symbol often associated with medicine and healthcare.

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

June 22, 2016

AGFA Healthcare N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager AGFA HealthCare Corporation 10 South Academy Street GREENVILLE SC 29601

Re: K161061

Trade/Device Name: IMPAX Volume Viewing 4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2016 Received: June 8, 2016

Dear Ms. Cavanagh:

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 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

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Indications for Use

510(k) Number (if known) K161061

Device Name IMPAX Volume Viewing 4.0

Indications for Use (Describe)

The Volume Viewing software is a visualization package for PACS workstations. It is intended to support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital mage processing tool, with optional functionality to facilitate visualization and measurement of vessel features.

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

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

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510(K) SUMMARY:

Agfa IMPAX Volume Viewing 4.0

SUBMITTER I.

Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Koen Cobbaert, Prepared: April 14, 2016 Telephone: +32 3 444 7539

II. DEVICE

Name of Device: IMPAX Volume Viewing 4.0 Common Name: System, Image Processing, Radiological Classification Name: Picture Archiving and Communications System (PACS) Regulatory Classification: Class II, 21 CFR 892.2050 Product Code: LLZ

III. PREDICATE DEVICES

This is a 510(k) for Agfa's IMPAX Volume Viewing 4.0, which is a picture archiving and communications system. It is substantially equivalent to Agfa's IMPAX Volume Viewing 3.0 (K133135) and TeraRecon's iNtuition 4.4.11 (K121916).

These predicates have not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

Principles of operation and technological characteristics of the new and predicate devices are the same.

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INTENDED USE

Other optional functionality is intended for the registration of anatomical (CT) on a second CT dataset or on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumour measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI), has a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and provides tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline.

Intended use has not changed as a result of any labeling modification(s).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH V. PREDICATE DEVICES

Agfa's IMPAX Volume Viewing 4.0 has an Indication for Use statement largely similar to the statements for the predicate devices (K133135, K121916). Intended uses are the same. As software accessories to PACS systems, the predicates and the new device have the same technological characteristics. The software is used to identify characteristic patterns within 3D image data which the user can then view and manipulate.

IMPAX Volume Viewing 4.0 comprises the same functionality to manipulate and analyze 3D image data as its primary predicate IMPAX Volume Viewing 3.0. The device subject of this submission however differs on the following technological characteristics:

1. The visualization algorithm for multi-planar reformatting (MPR) now employs a different interpolation. MPR visualization is present in the primary predicate IMPAX Volume Viewing 3.0, but uses a different algorithm.
1. It includes additional visualization tools for fly-through along a centerline intended for endoscopic viewing of vessels and airways. This functionality is present in the secondary predicate TeraRecon's inNuition, but uses proprietary algorithms,
1. New tools were added for the automated segmentation and management of lung lesions. This functionality is present in the secondary predicate TeraRecon's inNuition, but uses proprietary algorithms.

Descriptive characteristics and performance data are adequate to ensure equivalence.

Differences in devices do not alter the intended therapeutic/diagnostic effect.

IMPAX Volume Viewing 4.0 is an accessory to Agfa's IMPAX PACS systems. It is a general

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purpose medical image processing tool for the reading and analysis of 3D image datasets. It is the successor to Agfa's Volume Viewing 3.0 (K133135) and adds the following new functionality: a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline.

It is a tool for conveniently viewing and manipulating cross-sectional image series for display in any orientation and slice thickness. A second series can be registered or fused to the first automated, manually or with user defined landmarks. Automated table removal, removal of bonelike structures and segmentation of blood vessels and air-filled structures facilitate the visualization of vessels and airways. The software includes measurement tools for stenosis and lesions. A web-browser variant with a limited tool set provides remote access for review purposes.

In addition the software provides color maps, subtraction views, multiple screen layouts and anaglyphic images. Anaglyphic images are used to provide a stereoscopic 3D effect, when viewed with glasses where the two lenses are different (usually chromatically opposite) colors, such as red and cyan. Images are made up of two color lavers, superimposed, but offset with respect to each other to produce a depth effect. The stereoscopic 3D view is available next to the "regular" 3D view. A user can toggle the image from the regular 3D view to stereo 3D. Tests by medical professionals showed that there are no specific medical or clinical benefits to using the stereoscopic 3D view. It is perceived as useful to train medical students, but has no clinical benefits in comparison to the "regular" 3D view.

The table on the next page summarizes the similarities and differences between the new device and the predicates.

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	IMPAXVolume Viewing4.0NEW DEVICE	IMPAXVolume Viewing 3.0(K133135)PRIMARYPREDICATE	TeraReconiNtuition 4.4.11(K121916)PREDICATE
3D Volume rendering	SAME AS PREDICATES	√	√
MPR, CPR	SAME AS PREDICATES	√	√
MIP, MinIP, AvgIP	SAME AS PREDICATES	√	√
Fusion and subtractionviews	SAME AS PREDICATES	√	√
Can load and register twodata sets for comparison(landmark based,automated, manual)	SAME AS PREDICATES	√	√
Multi-modality (CT andMR) image registration	SAME AS PREDICATES	√	√
Anaglyphic stereo 3DViewing	SAME AS PREDICATES	√	√
Segmentation tools	SAME AS PREDICATES	√	√
Automated removal of theCT-table	SAME AS PREDICATES	√	√
Automated removal ofbone-like structures	SAME AS PREDICATES	√	√
Volume measurements	SAME AS PREDICATES	√	√
Semi-automatied regiongrowing	SAME AS PREDICATES	√	√
Vessel analysis	SAME AS PREDICATES	√	√
Stenosis measurements	SAME AS PREDICATES	√	√
AVI movie generation	SAME AS PREDICATES	√	√
Reformat to a new dataset	SAME AS PREDICATES	√	√
Color maps & Annotations	SAME AS PREDICATES	√	√
Intra- or internet access forreview purposes (mobileuse)	SAME AS PREDICATES	√	√
Lesion ManagementModule	SAME AS K121916	X	√
Automated lung nodulesegmentation	SAME AS K121916	X	√
Endoscopic fly-through forvessels and airways	SAME AS K121916	X	√
Calcium Scoring ofatherosclerotic plaque	SAME AS K133135	X	√
Interpretation ofmammography images	SAME AS K133135	X	√
Tumor evaluation usingRECIST criteria	SAME AS K133135	X	√
	IMPAXVolume Viewing4.0NEW DEVICE	IMPAXVolume Viewing 3.0(K133135)PRIMARYPREDICATE	TeraReconiNtuition 4.4.11(K121916)PREDICATE
Liver measurements	SAME AS K133135	X	√
Time-Volume Analysis(TVA), Cardiac functionand Time DependentAnalysis (TDA) of bloodflow	SAME AS K133135	X	√
Tools for EndovascularAortic Repair (for stentplacement)	SAME AS K133135	X	√
Virtual Colonoscopy	SAME AS K133135	X	√
User interface	SAME AS K133135	IMPAX	iNtuition
Indications for Use	1. Visualization package forPACS workstations.2. Support the medicalprofessional in the reading,analysis and diagnosis ofDICOM compliantvolumetric medical datasets.3. General purpose digitalmedical image processingtool, with optionalfunctionality to facilitatevisualization andmeasurement of vesselfeatures.4. Optional functionality -registration of anatomical(CT) on a second CT datasetor on functional volumetricimage data (MR) to facilitatethe comparison of variouslesions. Volume and distance image data (MR) tomeasurements - evaluationand quantification of tumormeasurements, and otheranalysis and evaluation ofboth hard and soft tissues.5. Supports interactivesegmentation of a region ofinterest (ROI), has adedicated tool set for lunglesion segmentation,quantification and follow-upof lesions selected by the userand provides tools to defineand edit paths such ascenterlines through structures.6. Web-browser access is	1. Visualization packagefor PACS workstations.2. Support the medicalprofessional in thereading, analysis anddiagnosis of DICOMcompliant volumetricmedical datasets.3. General purposedigital medical imageprocessing tool, withoptional functionality tofacilitate visualizationand measurement ofvessel features.4. Optional functionality- registration ofanatomical (CT) on asecond CT dataset or onfunctional volumetricimage data (MR) tofacilitate the comparisonof various lesions.Volume and distancemeasurements -evaluation andquantification of tumormeasurements, and otheranalysis and evaluationof both hard and softtissues.5. Supports interactivesegmentation of a regionof interest (ROI).6. Web-browser access isavailable for reviewpurposes. Images	1. Provide access to images via client-server software, web browser andmobile technology.2. Support healthcare professionalsassist physicians in diagnosis byreceiving, storing, transmitting, post-processing, displaying and allowingmanipulation of reports and medicalimages from acquisition devices,including optical or other non-DICOMformat images.3. Visualization in combination of 2D,3D and 4D are supported for single ormultiple datasets.4. Tools are provided to define andedit paths through structures such ascenterlines, which may be used toanalyze cross-sections of structures, orto provide flythrough visualizationsrendered. Region Segmentation andquantitative analysis tools - images ofvasculature, pathology andmorphology and tracking of quantitiesover time.5. Database - track and compareresults using published comparisontechniques. Calcium scoring forquantification of atherosclerotic plaqueand digital image processing to derivemetadata or new images from inputimage sets are supported. Imageprocessing - extract metadata to deriveparametric images from combinationsof multiple input images.6. Interpretation of mammographicimages or digitized film screen imagesis only supported when software is
IMPAXVolume Viewing4.0NEW DEVICE	IMPAXVolume Viewing 3.0(K133135)PRIMARYPREDICATE	TeraReconiNtuition 4.4.11(K121916)PREDICATE
available for review purposes.Images accessed through aweb-browser (via a mobiledevice or by other means)should not be used to create adiagnosis, treatment plan, orother decision that may affectpatient care.	accessed through a web-browser (via a mobiledevice or by othermeans) should not beused to create adiagnosis, treatment plan, or other decision thatmay affect patient care.	used without compression and with anFDA-Approved monitor. Not intendedto replace full workstations and shouldonly be used when there is no accessto a workstation. Not intended forweb-browser or mobile diagnostic use.

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Table 1: Device Comparison Table

VI. PERFORMANCE DATA

Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device.

There are no applicable FDA mandated performance standards for this device. However, Agfa's in-house standard operating procedures were used for the development of the software; these procedures conform to the following standards:

ISO 13485:2003 Medical Devices Quality Management Systems ●
ISO 14971:2007 Application of Risk Management to Medical Devices
ISO 27001:2013 Information Security Management ●
ISO 62366:2007 Medical Devices Application of usability engineering to medical devices ●
IEC 62304:2006 Medical Device Software Software life cycle processes ●

Verification

Verification tests for IMPAX Clinical Applications 4.0 covered all requirements and identified risk control measures.

Regression testing assured the different measurement algorithms still provide the same output as the previous version IMPAX Volume Viewing 3.0 (K133135). Testers made identical measurements of diameters, areas and volumes and compared those against reference values. Results met the established acceptance criteria of +/- scanner resolution (for dataset uncertainty).

The tests also included crosshair position checks to verify whether viewports link to the same location in every dataset. Results met the established acceptance criteria of half a voxel (for rounding differences across graphic video cards).

Validation

Agfa invited 3 radiologists from several Belgian hospitals to its facilities to evaluate the new functionality. In a lab environment the radiologists selected and loaded representative clinical

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datasets on IMPAX Clinical Applications 4.0 and its predicate devices. They executed typical workflows and scored the features under investigation. A scoring scale was implemented and acceptance criteria established. Results met acceptance criteria.

The tests concluded that IMPAX Clinical Applications 4.0 is substantially equivalent to the predicate iNtuition 4.4.11 in terms of endoscopic viewing of tubular structures (vessels and airways) and to the predicate IMPAX Volume Viewing 3.0 in terms of image rendering. Also the accuracy of the lung nodule segmentation and the capabilities of the lesion management module were scored. These features were found to be adequate to segment lesions, analyze them and follow-up on their growth over the time.

All verification and validation testing has been successfully completed.

Summary

Based on the performance data as documented in the above testing, IMPAX Volume Viewing 4.0 is found to have a safety and effectiveness profile that is similar to the predicate devices.

CONCLUSIONS VII.

The device has indications for use that are consistent with those of the legally marketed predicate devices. Where technological characteristics differ lab tests concluded that the device is substantially equivalent to the predicates in that it does not alter the intended therapeutic/diagnostic effect.

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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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).