uWS-MI is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

The PET/CT Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.

The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated timeactivity curve.

The PET/CT Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database.

The PET/CT Cardiac Analysis (ECTbTM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis and cardiac function analysis of the cardiac short axis.

Device Description

uWS-MI is a comprehensive software solution designed to process, review and analyze PET, CT and PET/CT patient studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, such as PET as well as anatomical datasets, such as CT. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean. maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.

AI/ML Overview

The acceptance criteria and study proving device performance are not explicitly detailed in the provided text in the format requested. However, based on the scattered information, I can infer some points and explicitly state what is missing.

The device is uWS-MI, a software solution for viewing, manipulation, and storage of medical images, with specific applications for PET/CT Oncology, PET/CT Dynamic Analysis, PET/CT Brain Analysis (NeuroQ™), and PET/CT Cardiac Analysis (ECTb™).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria and detailed quantitative results.

Here's an attempt to extract and synthesize the information based on your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Application	Acceptance Criteria (Implied)	Reported Device Performance
General Image Processing	Equivalent functionality to predicate device (K123920 Syngo.via)	All listed general functions (2D/3D review, filming, fusion, ROI/VOI, MIP display, compare) are "Same" as predicate.
PET/CT Dynamic Analysis	Equivalent functionality to reference device (K101749 Syngo™TrueD Software)	All listed functions (ROI Analysis, Pseudo color, Automatic cine, Curve Analysis, Table Statistics, Save, Filming) are "Same" as reference device. Reframe/Rebin functionality is present but differs from reference device, with a remark that it "will not impact the safety and effectiveness of the device."
PET/CT Oncology	Equivalent functionality to reference device (K063324 GE PET VCAR)	All listed functions (Compare display, Auto registration, Manual registration, Fix Segmentation, Adaptive Segmentation, Spread, Statistical Analysis, Save) are "Same" as reference device.
PET/CT Brain Analysis (NeuroQ™)	Equivalent functionality to reference device (K130451 NeuroQ™3.6)	All listed functions (Reformat, Quality Control, Slice Display, Compare, PET/CT Fusion, EQuAL analysis, AmyQ, Save results, Capture region/display, Exit) are "Same" as reference device.
PET/CT Cardiac Analysis (ECTb™)	Equivalent functionality to reference device (K130902 Emory Cardiac Toolbox™3.2)	All listed functions (Reconstruction, SSS, Polor Maps, Perfusion Analysis, Viability Analysis, Functional Analysis, Save results, Capture region/display, Exit) are "Same" as reference device.
Safety and Efficacy	Overall safety and effectiveness profile similar to predicate device.	"uWS-MI was found to have a safety and effectiveness profile that is similar to the predicate device."

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). However, it mentions "Performance evaluation Report for PET/CT Oncology and Image Fusion" as part of Performance Verification. Details about this report, including the data used, are not provided. Given the nature of a 510(k) summary, the data often comes from internal testing designed to show equivalence, rather than large-scale clinical trials.

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

This information is not provided in the document. Ground truth establishment details are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not specifically mentioned or detailed. The document focuses on demonstrating substantial equivalence based on features and software verification, and states "No clinical study was required." for general device clearance. The performance of specific applications (NeuroQ™ and ECTb™) leverages their prior clearances, implying that their functionalities, rather than a new comparative effectiveness study of the full uWS-MI system, were reviewed.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The device is described as "stand-alone software," and its primary verification listed is "Software Verification and Validation." This suggests that the performance verification would have evaluated the algorithm's output independently, as a standalone system. However, the exact metrics and results of this standalone performance are not explicitly provided beyond the statement of functional equivalence to predicate/reference devices.

7. Type of Ground Truth Used

The type of ground truth used for specific performance evaluations is not explicitly stated. However, considering the device's function as an image post-processing and analysis tool, the ground truth would typically involve:

Expert consensus or expert readings: For evaluating the accuracy of image analysis, measurements, or lesion segmentation outputs.
Pathology or clinical outcomes data: For validating the diagnostic accuracy of features, particularly for oncology applications, though "no clinical study was required" suggests this was not the primary method for this 510(k).
Phantom or synthetic data: For testing algorithm robustness and accuracy in controlled environments.

Since the PET/CT Brain Analysis (NeuroQ™) and PET/CT Cardiac Analysis (ECTb™) applications were cleared previously, their ground truth would have been established during their initial clearances, likely involving expert-derived truth based on clinical images or phantoms.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of any training set. As a 510(k) for a software device, the focus is often on functional equivalence and verification/validation, rather than detailing the machine learning model training process if such models are embedded.

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

This information is not provided in the document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.

Shanghai United Imaging Healthcare Co., Ltd. % Shumei Wang QM&RA, VP, Jiading District No. 2258 Chengbei Road Shanghai. 201807 CHINA

April 5, 2018

Re: K172998

Trade/Device Name: uWS-MI Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 30, 2018 Received: April 2, 2018

Dear Shumei Wang:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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) K172998

Device Name uWS-MI

Indications for Use (Describe)

The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated timeactivity curve.

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

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510 (k) SUMMARY

Date of Preparation: 1. March 29, 2018

2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Establishment Registration Number: Not yet registered or the Number

Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com

3. Identification of Proposed Device

Trade Name: uWS-MI Common Name: PET/CT Image Post-Processing Software Model(s): uWS-MI

Regulatory Information Classification Name: Picture archiving and communications system Classification: II Product Code: LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology

4. Identification of Predicate Device(s)

Predicate Device 510(k) Number: K123920 Device Name: Syngo.via

Reference Device#1 510(k) Number: K101749 Device Name: Syngo™TrueD Software

Reference Device#2 510(k) Number: K063324 Device Name: PET VCAR

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Reference Device#3 510(k) Number: K130451 Device Name: NeuroQ"M3.6

Reference Device#4 510(k) Number: K130902 Device Name: Emory Cardiac Toolbox™3.2

5. Device Description

6. Indications for Use

uWS-MI is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

. The PET/CT Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.
. The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated time-activity curve.
. The PET/CT Brain Analysis (NeuroQ 100) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database.
. The PET/CT Cardiac Analysis (ECTbTM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis, activity analysis and cardiac function analysis of the cardiac short axis.

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Summary of Technological Characteristics 7.

uWS-MI is a medical diagnostic application for viewing, manipulation, 3D visualization, post-processing and comparison of medical images. After importing the DICOM image data into the system, the operator is able to perform image browsing and processing and can further obtain advanced information for diagnosis. This is identical to the predicate device.

The following tables compare the main features, principles of operation, fundamental scientific technology and intended use of uWS-MI when compared to the predicate devices.

Substantially Equivalent (SE) Comparison 8.

The proposed device has similar indications for use, provides similar overall

functions and performs in a similar manner with the predicate device and reference devices.

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Table 1 SE discussion for basic functions

Item	Proposed Device	Predicate Device	Remark
General	uWS-MI	syngo.via(K123920)
DeviceClassificationName	Picture Archiving andCommunications System	Picture Archiving andCommunications System	Same
Product Code	LLZ	LLZ	Same
RegulationNumber	21 CFR 892.2050	21 CFR 892.2050	Same
Device Class	II	II	Same
ClassificationPanel	Radiology	Radiology	Same
Specification
Imagecommunication	Standard network protocols likeTCP/IP and standardcommunication protocol DICOM.Additional fast image.	Standard network protocols like TCP/IPand standard communication protocolDICOM. Additional fast image.	Same
Hardware /OS	Windows 7	Windows 7	Same
PatientAdministration	Display and manage the image datainformation of all patients stored inthe database.	Display and manage the image datainformation of all patients stored in thedatabase.	Same
Review 2D	2D Review consists of basicprocessing of the 2D images, e.g.rotation, scaling, translation,windowing, and measurements.	2D Review consists of basic processingof the 2D images, e.g. rotation, scaling,translation, windowing, andmeasurements.	Same
Review 3D	3D Review consist of	3D Review consist of functionalities for	Same
Item	Proposed Device	Predicate Devicesyngo.via(K123920)	Remark
	uWS-MIfunctionalities for displaying andprocessing image in the 3D form,e.g. VR, CPR, MPR, MIP, etc. Themodule also includes tools for VOIanalysis.	displaying and processing image in the3D form, e.g. VR, CPR, MPR, MIP, etc.The module also includes tools for VOIanalysis.
Filming	Filming is a module dedicated forimage printing. The print toolsprovide layout editing for bothsingle images and series.	Filming is a module dedicated for imageprinting. The print tools provide layoutediting for both single images and series.	Same
Fusion	Including Auto registration,Manual registration, Spotregistration	Including Auto registration, Manualregistration, Spot registration	Same
Inner View	Inner view the vessel , colon ,trachea	Inner view the vessel , colon , trachea	Same
Visibility	User-defined the display property offused image: Adjustment of presetof T/B value; Adjustment of thefused rate; Adjustment of pse	User-defined the display property offused image: Adjustment of preset of T/Bvalue; Adjustment of the fused rate;Adjustment of pse	Same
ROI/VOI	Plotting ROI or VOI, and obtainingthe maximum activity value, theminimum activity value, meanactivity value, the volume/area ofregion, and the maximum diameterof volume, peak activity value;	Plotting ROI or VOI, and obtaining themaximum activity value, the minimumactivity value, mean activity value, thevolume/area of region, and the maximumdiameter of volume, peak activity value;	Same
MIP Display	The image can be displayed as MIPand rotating play	The image can be displayed as MIP androtating play	Same
Compare	Load two studies to compare	Load two studies to compare	Same

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Table 2 SE discussion for advanced applications

Application	Function name	Proposed deviceuWS-MI	Referencedevice#1:SyngoTM TrueDSoftware(K101749)	Referencedevice#2:GE PETVCAR(K063324)	Referencedevice#3:NeuroqTM3.6(K130451)	Referencedevice#4:SyntermedEmoryCardiacToolboxTM3.2 (K130902)	Remark
PET/CTDynamicAnalysis	Reframe/Rebin	Yes	Do not have thefunction of datareframe	/	/	/	The Reframe/Rebinmodule is appliedto generatecombined data ofany time phasedefined by the user.This difference willnot impact thesafety andeffectiveness of thedevice.
	ROI Analysis	Yes	Yes	/	/	/	Same
	Pseudo color	Yes	Yes	/	/	/	Same
	Automatic cine	Yes	Yes	/	/	/	Same
	Curve Analysis	Yes	Yes	/	/	/	Same
	Table Statistics	Yes	Yes	/	/	/	Same
	Save	Yes	Yes	/	/	/	Same
	Filming	Yes	Yes	/	/	/	Same
PET/CTOncology	Comparedisplay	Yes	/	Yes	/	/	Same
	Autoregistration	Yes	/	Yes	/	/	Same
Application	Function name	Proposed deviceuWS-MI	Referencedevice#1:SyngoTMTrueDSoftware(K101749)	Referencedevice#2:GE PETVCAR(K063324)	Referencedevice#3:NeuroqTM3.6(K130451)	Referencedevice#4:SyntermedEmoryCardiacToolboxTM3.2 (K130902)	Remark
	Manualregistration	Yes	/	Yes	/	/	Same
	FixSegmentation	Yes	/	Yes	/	/	Same
	AdaptiveSegmentation	Yes	/	Yes	/	/	Same
	Spread	Yes	/	Yes	/	/	Same
	StatisticalAnalysis	Yes	/	Yes	/	/	Same
	Save	Yes	/	Yes	/	/	Same
	Reformat	Yes	/	/	Yes	/	Same
	Quality Control	Yes	/	/	Yes	/	Same
	Slice Display	Yes	/	/	Yes	/	Same
PET/CTBrainAnalysis	Compare	Yes	/	/	Yes	/	Same
	PET/CT Fusion	Yes	/	/	Yes	/	Same
	EQuAL analysis	Yes	/	/	Yes	/	Same
(NeuroqTM3.6)	AmyQ	Yes	/	/	Yes	/	Same
	Save results,Captureregion/display ,Exit	Yes	/	/	Yes	/	Same
PET/CT	Reconstruction	Yes	/	/	/	Yes	Same
Application	Function name	Proposed deviceuWS-MI	Referencedevice#1:SyngoTMTrueDSoftware(K101749)	Referencedevice#2:GE PETVCAR(K063324)	Referencedevice#3:NeuroqTM3.6(K130451)	Referencedevice#4:SyntermedEmoryCardiacToolboxTM3.2 (K130902)	Remark
CardiacAnalysis(EmoryCardiacToolboxTM3.2)	SSS	Yes	/	/	/	Yes	Same
	Polor Maps	Yes	/	/	/	Yes	Same
	PerfusionAnalysis	Yes	/	/	/	Yes	Same
	ViabilityAnalysis	Yes	/	/	/	Yes	Same
	FunctionalAnalysis	Yes	/	/	/	Yes	Same
	Save results,Captureregion/display ,Exit	Yes	/	/	/	Yes	Same

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9. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

Not Applicable to the proposed device, because the device is stand-alone software.

Electrical Safety and Electromagnetic Compatibility (EMC)

Not Applicable to the proposed device, because the device is stand-alone software.

Software Verification and Validation

Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device. This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern (LOC). These documentations include:

Software description
Hazard Analysis
· Software requirements specification (SRS)
· Software Architecture Description
· Software Development Environment Description
· Software Verification and Validation
· Cyber security Documents

Animal Study

No animal study was required.

Clinical Studies

No clinical study was required.

Performance Verification

Performance evaluation Report for PET/CT Oncology and Image Fusion
. The PET/CT Brain Analysis (NeuroQ100) application was cleared by FDA under K130451 on May 17th 2013
The PET/CT Cardiac Analysis (ECTb™) application was cleared by FDA under . K130902 on June 14th 2013.

Product Standards and Guidance

NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).

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ISO 14971 Medical devices - Application of risk management to medical devices (Edition 2.0, corrected version, 2007).
. IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015).

Summary

The features described in this premarket submission are supported with the results of the testing mentioned above. The uWS-MI was found to have a safety and effectiveness profile that is similar to the predicate device.

10. Substantially Equivalent (SE) Conclusion

The proposed device is equivalent to the predicate device with regard to safety and efficacy. This conclusion is based upon a comparison of intended use, technological characteristics, performance specification, device hazards as well as verification and validation results.

In summary, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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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).