uWS-CT 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 CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation of suspicious lesions in lung or liver. The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.

The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw. The CT Lung Density application is intended to provide the user a number of density parameters and structure information for evaluating tomogram scans of the lung.

The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.

The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating CT vascular images.

The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.

Device Description

uWS-CT is a comprehensive software solution designed to process, review and analyze CT 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, as well as anatomical datasets. 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 provided document is a 510(k) Premarket Notification from Shanghai United Imaging Healthcare Co., Ltd. for their device uWS-CT. This document outlines the device's indications for use, technological characteristics, and comparison to predicate devices, but it does not contain a detailed study demonstrating that the device meets specific acceptance criteria based on human-in-the-loop or standalone performance.

Instead, the document primarily focuses on demonstrating substantial equivalence to predicate devices based on similar functionality and intended use, supported by software verification and validation testing, hazard analysis, and performance evaluations for various CT applications. It explicitly states that "No clinical study was required." and "No animal study was required." for this submission.

Therefore, I cannot provide the detailed information requested in the prompt's format (acceptance criteria table, sample size, expert ground truth, MRMC study, etc.) because these types of studies were not conducted or reported in this 510(k) submission.

The "Performance Data" section (Page 11) lists "Performance Evaluation Report For CT Lung Nodule," "Performance Evaluation Report For CT Oncology," etc., but these are internal reports that are not detailed in this public document. They likely refer to internal testing that verifies the software's functions perform as designed, rather than robust clinical performance studies against specific quantitative acceptance criteria with human readers or well-defined ground truth beyond internal validation.

What is present in the document regarding "performance" is:

Software Verification and Validation: This typically involves testing that the software functions as designed, is free of bugs, and meets its specified requirements. The document mentions "hazard analysis," "software requirements specification (SRS)," "software architecture description," "software development environment description," "software verification and validation," and "cyber security documents."
Performance Evaluation Reports for specific applications: These are listed but not detailed (e.g., CT Lung Nodule, CT Oncology). It's implied these show the software functions correctly for those applications.

In summary, based on the provided text, there is no information about:

A table of acceptance criteria with reported device performance in the context of clinical accuracy or diagnostic performance.
Sample sizes used for a test set in a clinical performance study.
Data provenance for a clinical test set.
Number of experts or their qualifications for establishing clinical ground truth.
Adjudication methods for a clinical test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone (algorithm-only) performance studies against clinical ground truth.
Type of clinical ground truth used (pathology, outcomes data, expert consensus from an external panel).
Sample size for a training set (as no AI/ML model requiring a training set is explicitly discussed in terms of its performance data; the device is described as "CT Image Post-Processing Software" with various applications.)
How ground truth for a training set was established.

The closest the document comes to "acceptance criteria" and "performance" are discussions of functional equivalence to predicate devices and general software validation, stating that the proposed device performs in a "similar manner" and has a "safety and effectiveness profile that is similar to the predicate device."

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration written in blue text.

November 7, 2018

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

Re: K173001

Trade/Device Name: uWS-CT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2018 Received: October 10, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-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.

Hole 2. Nils

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) K173001

Device Name uWS-CT

Indications for Use (Describe)

The CT Vessel Analysis application is intended to provide a tool for viewing, manipulating CT vascular images.

The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.

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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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, also in a bold, sans-serif font. The color of the text and symbol is a dark teal.

510 (k) SUMMARY

K173001

Date of Preparation: 1. March 26, 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 for 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-CT Common Name: CT Image Post-Processing Software Model(s): uWS-CT

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: K033326 Device Name: "Philips Plus" CT Scanner

Reference device#2 510(k) Number: K162025 Device Name: IntelliSpace Portal Platform

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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in bold. The logo is simple and modern, and the colors are muted.

Reference device#3 510(k) Number: K081985 Device Name: AW SERVER

Reference device#4 510(k) Number: K023785 Device Name: Lung Nodule Assessment and Comparison Option (LNA)

Device Description 5.

Indications for use 6.

uWS-CT 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 CT Oncology application is intended to support fast-tracking routine diagnostic oncology, staging, and follow-up, by providing a tool for the user to perform the segmentation and volumetric evaluation of suspicious lesions in lung or liver.
The CT Colon Analysis application is intended to provide the user a tool to enable easy visualization and efficient evaluation of CT volume data sets of the colon.
The CT Dental application is intended to provide the user a tool to reconstruct panoramic and paraxial views of jaw.
. The CT Lung Density application is intended to provide the user a number of density parameters and structure information for evaluating tomogram scans of the lung.
. The CT Lung Nodule application is intended to provide the user a tool for the review and analysis of thoracic CT images, providing quantitative and characterizing information about nodules in the lung in a single study, or over the time course of several thoracic studies.

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, also in a bold font. The color of the text and the "U" shape is a dark teal.

The CT Vessel Analysis application is intended to provide a tool for viewing. manipulating, and evaluating CT vascular images.
. The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.

7. Summary of Technological Characteristics

uWS-CT 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-CT when compared to the predicate devices.

8. Substantially Equivalent (SE) Comparison

The proposed device has similar indications for use and overall function and performs in a similar manner with respect to, display, review and processing applications with predicate device and reference device.

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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the words is a stylized "U" shape that is dark blue. The logo is simple and modern.

Table 1 SE Discussion for basic functions

Item	Proposed Device	Predicate Device	Remark
	uWS-CT	syngo.via(K123920)
General
Device ClassificationName	Picture Archiving and Communications System	Picture Archiving and Communications System	Same
Product Code	LLZ	LLZ	Same
Regulation Number	21 CFR 892.2050	21 CFR 892.2050	Same
Device Class	II	II	Same
Classification Panel	Radiology	Radiology	Same
Specification
Image communication	Standard network protocols like TCP/IP andstandard communication protocol DICOM.Additional fast image.	Standard network protocols like TCP/IP andstandard communication protocol DICOM.Additional fast image.	Same
Hardware /OS	Windows 7	Windows 7	Same
Patient Administration	Display and manage the image data informationof all patients stored in the database.	Display and manage the image data information ofall patients stored in the database.	Same
Review 2D	2D Review consists of basic processing of the 2Dimages, e.g. rotation, scaling, translation,windowing, and measurements.	2D Review consists of basic processing of the 2Dimages, e.g. rotation, scaling, translation,windowing, and measurements.	Same
Review 3D	3D Review consist of functionalities fordisplaying and processing image in the 3D form,e.g. VR, CPR, MPR, MIP, etc. The module alsoincludes tools for VOI analysis.	3D Review consist of functionalities fordisplaying and processing image in the 3D form,e.g. VR, CPR, MPR, MIP, etc. The module alsoincludes tools for VOI analysis.	Same
Filming	Filming is a module dedicated for image printing.The print tools provide layout editing for bothsingle images and series.	Filming is a module dedicated for image printing.The print tools provide layout editing for bothsingle images and series.	Same
Fusion	Including registration, Manual registration, Spotregistration	Including registration, Manual registration, Spotregistration	Same
Inner View	Inner view the vessel, colon, trachea	Inner view the vessel, colon, trachea	Same
Item	Proposed Device	Predicate Device	Remark
	uWS-CT	syngo. via(K123920)
Visibility	User-defined the display property of fused	User-defined the display property of fused image:	Same
	image: Adjustment of preset of T/B value;	Adjustment of preset of T/B value; Adjustment of
	Adjustment of the fused rate; Adjustment of pse	the fused rate; Adjustment of pse
ROI/VOI	Plotting ROI or VOI, and obtaining the	Plotting ROI or VOI, and obtaining the maximum	Same
	maximum activity value, the minimum activity	activity value, the minimum activity value, mean
	value, mean activity value, the volume/area of	activity value, the volume/area of region, and the
	region, and the maximum diameter of volume,	maximum diameter of volume, peak activity value;
	peak activity value;
MIP Display	The image can be displayed as MIP and rotating	The image can be displayed as MIP and rotating	Same
	play	play
Compare	Load two studies to compare.	Load two studies to compare.	Same

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Table 2 SE discussion for additional applications

Application	Function name	ProposeddeviceuWS-CT	PredicateDevicesyngo. via(K123920)	Referencedevice#1:"Philips Plus"CT Scanner(K033326)	Referencedevice#2:IntelliSpacePortalPlatform(K162025)	Referencedevice#3:AWSERVER(K081985)	Referencedevice#4:Lung NoduleAssessment andComparisonOption (LNA)(K023785)	Remark
CT Lungdensity	Lung and TracheaSegmentation	Yes	/	Yes	/	/	/	Same
	Calculation of LungDensity	Yes	/	Yes	/	/	/	Same
	Histogram Analysis	Yes	/	Yes	/	/	/	Same
	Table Statistics	Yes	/	Yes	/	/	/	Same
	VRT Protocol Display	Yes	/	Yes	/	/	/	Same
	Save, Report, Print	Yes	/	Yes	/	/	/	Same
Application	Function name	ProposeddeviceuWS-CT	PredicateDevicesyngo. via(K123920)	Referencedevice#1:"Philips Plus"CT Scanner(K033326)	Referencedevice#2:IntelliSpacePortalPlatform(K162025)	Referencedevice#3:AWSERVER(K081985)	Referencedevice#4:Lung NoduleAssessment andComparisonOption (LNA)(K023785)	Remark
CT Oncology	Compare display	Yes	/	Yes	/	/	/	Same
	Registration	Yes	/	Yes	/	/	/	Same
	Manual registration	Yes	/	Yes	/	/	/	Same
	lung nodulessegmentation	Yes	/	Yes	/	/	/	Same
	liver lesionssegmentation	Yes	/	Yes	/	/	/	Same
	Spread	Yes	/	Yes	/	/	/	Same
	Statistical Analysis	Yes	/	Yes	/	/	/	Same
	Save, Report, Print	Yes	/	Yes	/	/	/	Same
CT DentalApplication	Setting ReferenceLine in 3D MIPImage	Yes	/	Yes	/	/	/	Same
	Plotting PanoramicCurve	Yes	//	Yes	/	/	/	Same
	Marking Nerve Lines	Yes	/	Yes	/	/	/	Same
	Sectional ViewAnalysis	Yes	/	Yes	/	/	/	Same
	Dental VRT Display	Yes	/	Yes	/	/	/	Same
	Save	Yes	/	Yes	/	/	/	Same
	Print	Yes	/	Yes	/	/	/	Same
	Report	Yes	/	Yes	/	/	/	Same
	Pre-processing	Yes	/	Yes	/	/	/	Same
Application	Function name	ProposeddeviceuWS-CT	PredicateDevicesyngo. via(K123920)	Referencedevice#1:"Philips Plus"CT Scanner(K033326)	Referencedevice#2:IntelliSpacePortalPlatform(K162025)	Referencedevice#3:AWSERVER(K081985)	Referencedevice#4:Lung NoduleAssessment andComparisonOption (LNA)(K023785)	Remark
CT ColonAnalysis	Electronic ColonCleansing	Yes	/	Yes	/	/	/	Same
	Manual PolypsLabeling	Yes	/	Yes	/	/	/	Same
	Polyps' QuantitativeCalculation andAnalysis	Yes	/	Yes	/	/	/	Same
	Virtual Endoscopy	Yes	/	Yes	/	/	/	Same
	Multi-Views Display	Yes	/	Yes	/	/	/	Same
	Colon edit	Yes	/	Yes	/	/	/	Same
	Save, Report, Print	Yes	/	Yes	/	/	/	Same
CT VesselAnalysis	Blood Vessel CenterLines Extraction	Yes	/	Yes	/	/	/	Same
	VOI Segmentation	Yes	/	Yes	/	/	/	Same
	OrganizationsManagement	Yes	/	Yes	/	/	/	Same
	Vessel Tracking	Yes	/	Yes	/	/	/	Same
	Filter floaters	Yes	/	Yes	/	/	/	Same
	Save, Report, Print	Yes	/	Yes	/	/	/	Same
	One click BonesRemoval	Yes	/	/	Yes	/	/	Same
	DSA Bone Removal	Yes	Yes	/	/	/	/	Same
	VascularMeasurement	Yes	/	/	/	Yes	/	Same
Application	Function name	ProposeddeviceuWS-CT	PredicateDevicesyngo. via(K123920)	Referencedevice#1:"Philips Plus"CT Scanner(K033326)	Referencedevice#2:IntelliSpacePortalPlatform(K162025)	Referencedevice#3:AWSERVER(K081985)	Referencedevice#4:Lung NoduleAssessment andComparisonOption (LNA)(K023785)	Remark
CT LungNodule	Mark the nodule	Yes	/	Yes	/	/	/	Same
	Compare the study	Yes	/	Yes	/	/	/	Same
	Save, Report, Print	Yes	/	Yes	/	/	/	Same
	Lung Segmentation	Yes	/	/	/	/	Yes	Same
	Nodule Segmentation	Yes	/	/	/	/	Yes	Same
	Measurement	Yes	/	/	/	/	Yes	Same

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Image /page/9/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font, with "UNITED" stacked on top of "IMAGING". To the right of the text is a stylized "U" symbol, which is dark blue. The logo is simple and modern.

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Image /page/10/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark blue and has a white line running vertically through the center.

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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles a shield or a letter "U" with a horizontal line through the middle. The color of the text and symbol is a dark gray or teal.

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). Those 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 CT Lung Nodule
Performance Evaluation Report For CT Oncology
Performance Evaluation Report For CT Colonoscopy
Performance Evaluation Report For CT Fusion
Performance Evaluation Report For CT Inner View
. Performance Evaluation Report For CT Vessel

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Image /page/12/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font, stacked on two lines. To the right of the text is a stylized icon that resembles the letter "U" with a horizontal line through the middle, creating a negative space "I" shape. The logo is simple and modern in design.

Other Standards and Guidance

. NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
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-CT was found to have a safety and effectiveness profile that is similar to the predicate device and reference devices.

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 and reference devices.

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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).