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

The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.

The Dynamic application is intended to provide a general post-processing tool for time course studies.

The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.

MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.

The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.

The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced timecourse images.

The Brain Perfusion application is intended to allow the visualizations in the dynamic susceptibility time series of MR datasets.

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

Device Description

uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) 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 for the uWS-MR software. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a novel AI-powered diagnostic device.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design for proving the device meets those criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be fully extracted from this document.

Here's what can be inferred and stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a pass/fail format nor provide specific, measurable performance metrics for the proposed device (uWS-MR) in comparison to such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing their features and functionalities. The "Remark" column consistently states "Same," indicating that the proposed device's features align with its predicates, implying it meets comparable performance.

Feature Type (Category)	Proposed Device (uWS-MR) Performance (Inferred)	Predicate Device (syngo.via/Reference Devices) Performance (Inferred to be matched)	Remark/Acceptance (Inferred)
General
Device Classification Name	Picture Archiving and Communications System	Picture Archiving and Communications System	Same (Acceptable)
Product Code	LLZ	LLZ	Same (Acceptable)
Regulation Number	21 CFR 892.2050	21 CFR 892.2050	Same (Acceptable)
Device Class	II	II	Same (Acceptable)
Classification Panel	Radiology	Radiology	Same (Acceptable)
Specification
Image communication	Standard network protocols like TCP/IP and DICOM. Additional fast image.	Standard network protocols like TCP/IP and DICOM. Additional fast image.	Same (Acceptable)
Hardware / OS	Windows 7	Windows 7	Same (Acceptable)
Patient Administration	Display and manage image data information of all patients stored in the database.	Display and manage image data information of all patients stored in the database.	Same (Acceptable)
Review 2D	Basic processing of 2D images (rotation, scaling, translation, windowing, measurements).	Basic processing of 2D images (rotation, scaling, translation, windowing, measurements).	Same (Acceptable)
Review 3D	Functionalities for displaying and processing image in 3D form (VR, CPR, MPR, MIP, VOI analysis).	Functionalities for displaying and processing image in 3D form (VR, CPR, MPR, MIP, VOI analysis).	Same (Acceptable)
Filming	Dedicated for image printing, layout editing for single images and series.	Dedicated for image printing, layout editing for single images and series.	Same (Acceptable)
Fusion	Auto registration, Manual registration, Spot registration.	Auto registration, Manual registration, Spot registration.	Same (Acceptable)
Inner View	Inner view of vessel, colon, trachea.	Inner view of vessel, colon, trachea.	Same (Acceptable)
Visibility	User-defined display property of fused image: Adjustment of preset of T/B value; Adjustment of the fused.	User-defined display property of fused image: Adjustment of preset of T/B value; Adjustment of the fused.	Same (Acceptable)
ROI/VOI	Plotting ROI/VOI, obtaining max/min/mean activity value, volume/area, max diameter, peak activity value.	Plotting ROI/VOI, obtaining max/min/mean activity value, volume/area, max diameter, peak activity value.	Same (Acceptable)
MIP Display	Image can be displayed as MIP and rotating play.	Image can be displayed as MIP and rotating play.	Same (Acceptable)
Compare	Load two studies to compare.	Load two studies to compare.	Same (Acceptable)
Advanced Applications (Examples)
MR Brain Perfusion: Type of imaging scans	MRI	MRI	Same (Acceptable)
MR Breast Evaluation: Automatic Subtraction	Yes	Yes	Same (Acceptable)
MR Stitching: Automatic Stitching	Yes	Yes	Same (Acceptable)
MR Vessel Analysis: Automatic blood vessel center lines extraction	Yes	Yes	Same (Acceptable)
MRS: Single-voxel Spectrum Data Analysis	Yes	Yes	Same (Acceptable)
MR Dynamic/MAPS: ADC and eADC Calculate	Yes	Yes	Same (Acceptable)

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

The document states: "Software verification and validation testing was provided to demonstrate safety and efficacy of the proposed device." and lists "Performance Verification" for various applications. However, it does not specify the sample size used for these performance tests (test set) or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the document. The filing focuses on technical and functional equivalence, not on clinical performance evaluated against expert ground truth.

4. Adjudication Method

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed or required. The submission is a 510(k) for substantial equivalence, which often relies more on technical verification and comparison to predicate devices rather than new clinical effectiveness studies.

6. Standalone Performance

The document clearly states: "Not Applicable to the proposed device, because the device is stand-alone software." This implies that the device is intended to perform its functions (viewing, manipulation, post-processing) as a standalone software, and its performance was evaluated in this standalone context during verification and validation, aligning with the predicates which are also software solutions. However, no specific standalone performance metrics are provided.

7. Type of Ground Truth Used

The document does not explicitly state the "type of ground truth" used for performance verification. Given the nature of the device (image post-processing software) and the 510(k) pathway, performance verification likely involved:

Technical validation: Comparing outputs of uWS-MR's features (e.g., image stitching, parameter maps, ROI measurements) against known good results, simulated data, or outputs from the predicate devices.
Functional testing: Ensuring features operate as intended (e.g., if a rotation function rotates the image correctly).
Pathology or outcomes data are typically used for diagnostic devices with novel clinical claims, which is not the primary focus here.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning or AI models that learn from data. While the uWS-MR is post-processing software, and could potentially incorporate AI elements (though not explicitly stated beyond general "post-processing"), the document does not mention a training set size. This strongly suggests that a machine learning or deep learning model with a distinct training phase, as commonly understood, was not a primary component evaluated in this filing or, if present, its training data details were not part of this summary.

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

As no training set is mentioned (see point 8), the establishment of its ground truth is not applicable and therefore not described in the document.

Summary

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November 7, 2018

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

Re: K172999

Trade/Device Name: uWS-MR 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.

Hol 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) K172999

Device Name uWS-MR

Indications for Use (Describe)

The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.

The Dynamic application is intended to provide a general post-processing tool for time course studies.

The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.

The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced timecourse images.

The Brain Perfusion application is intended to allow the visualizations in the dynamic susceptibility time series of MR datasets.

Type of Use (Select one or both, as applicable)
X 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 logo consists of the words "UNITED IMAGING" 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 gray and has a white horizontal line through the middle. The overall design is clean and modern.

K172999

510 (k) SUMMARY

1. Date of Preparation: 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 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-MR Common Name: MR Image Post-Processing Software Model(s): uWS-MR

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: K151353 Device Name: Syngo.MR Neurology, Syngo.MR Oncology

Reference Device#2 510(k) Number: K130749 Device Name: syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular

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Reference Device#3 510(k) Number: K120315 Device Name: syngo.MR Spectroscopy

Reference Device#4

510(k) Number: K133401 Device Name: syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General

Reference Device#5 510(k) Number: K960265 Device Name: Advantage Windows with FuncTool Option

Reference Device#6 510(k) Number: K090546 Device Name: Nordic Image Control and Evaluation (nordicICE) Software

Reference Device#7 510(k) Number: K081985 Device Name: AW Server

5. Device Description

6. Indications for use

uWS-MR 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 MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
. The Dynamic application is intended to provide a general post-processing tool for time course studies.
. The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.

SECTION 2 - 3 of 11

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. MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
. The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.
. The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.
. MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR 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-MR comprises the post-processing applications for viewing, manipulation, 3D visualization, post-processing and comparison of MR 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. 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-MR 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 devices.

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

Item	Proposed DeviceuWS-MR	Predicate Devicesyngo.via(K123920)	Remark
General
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 protocolDICOM. Additional fast image.	Standard network protocolslike TCP/IP and standardcommunication protocolDICOM. Additional fastimage.	Same
Hardware /OS	Windows 7	Windows 7	Same
PatientAdministration	Display and manage the imagedata information of all patientsstored in the database.	Display and manage the imagedata information of all patientsstored in the database.	Same
Review 2D	2D Review consists of basicprocessing of the 2D images,e.g. rotation, scaling,translation, windowing, andmeasurements.	2D Review consists of basicprocessing of the 2D images,e.g. rotation, scaling,translation, windowing, andmeasurements.	Same
Review 3D	3D Review consist offunctionalities for displayingand processing image in the 3Dform, e.g. VR, CPR, MPR,MIP, etc. The module alsoincludes tools for VOI analysis.	3D Review consist offunctionalities for displayingand processing image in the 3Dform, e.g. VR, CPR, MPR,MIP, etc. The module alsoincludes tools for VOI analysis.	Same
Filming	Filming is a module dedicatedfor image printing. The printtools provide layout editing forboth single images and series.	Filming is a module dedicatedfor image printing. The printtools provide layout editing forboth single images and series.	Same
Fusion	Including Auto registration,Manual registration, Spotregistration	Including Auto registration,Manual registration, Spotregistration	Same
Inner View	Inner view the vessel , colon ,trachea	Inner view the vessel , colon ,trachea	Same
Visibility	User-defined the displayproperty of fused image:Adjustment of preset of T/Bvalue; Adjustment of the fused	User-defined the displayproperty of fused image:Adjustment of preset of T/Bvalue; Adjustment of the fused	Same
Item	Proposed DeviceuWS-MR	Predicate Devicesyngo.via(K123920)	Remark
ROI/VOI	Plotting ROI or VOI, andobtaining the maximum activityvalue, the minimum activityvalue, mean activity value, thevolume/area of region, and themaximum diameter of volume,peak activity value;	Plotting ROI or VOI, andobtaining the maximumactivity value, the minimumactivity value, mean activityvalue, the volume/area ofregion, and the maximumdiameter of volume, peakactivity value;	Same
MIP Display	The image can be displayed asMIP and rotating play	The image can be displayed asMIP and rotating play	Same
Compare	Load two studies to compare.	Load two studies to compare.	Same

SECTION 2 - 5 of 11

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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED" is stacked on top of the text "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized, dark teal-colored symbol that resembles a shield or a stylized letter "U" with a vertical line running through the center.

Table 2 SE Discussion for advanced applications

Application	Function name	ProposeddeviceuWS-MR	ReferenceDevice#1Syngo.MRNeurology,Syngo.MROncology(K151353)	ReferenceDevice#6Nordic ImageControl andEvaluation(nordicICE)Software(K090546)	Remark
MR BrainPerfusion	Type of imagingscans	MRI	MRI	/	Same
	Intended Body part	MRneurologicalimages.	MRneurologicalimages.	/	Same
	Rectify motion	Yes	Yes	/	Same
	Remove background	Yes	Yes	/	Same
	Arterial Select:Automatically ormanually selectarterial location.	Yes	Yes	/	Same
	Parametric MappingCalculation	Yes	/	Yes	Same
	TIC Analysis	Yes	Yes	/	Same
	Save Image Data	Yes	Yes	/	Same
	Print Image Data	Yes	Yes	/	Same
	Report	Yes	Yes	/	Same

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Image /page/8/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, with a white line running vertically through the center. The logo is simple and modern, and the use of bold font and a strong color makes it easily recognizable.

Application	Function name	Proposed device	Reference Device#4	Reference Device#5	Remark
MR Breast Evaluation	Type of imaging scans	MRI	MRI	MRI	Same
	Intended Body part	Breast	Breast	Breast	Same
	Automatic Subtraction	Yes	Yes	Yes	Same
	Motion Correction	Yes	Yes	Yes	Same
	TIC Analysis	Yes	Yes	Yes	Same
	Background Removal	Yes	Yes	Yes	Same
	TIC Analysis	Yes	Yes	Yes	Same
	Automatic Parameter Map Calculation	Yes	Yes	Yes	Same
	Save Image Data	Yes	Yes	Yes	Same
	Print Image Data	Yes	Yes	Yes	Same
	Report	Yes	Yes	Yes	Same
			syngo.MRNeurology,syngo.MROncology,syngo.MRBreVis andsyngo.mMRGeneral(K133401)	AdvantageWindowswithFuncToolOption(K960265)

Application	Function name	ProposeddeviceuWS-MR	Reference Device#2syngo.MR General,syngo.MR Cardiology andsyngo.MR Vascular(K130749)	Remark
MR Stitching	Type of imagingscans	MRI	MRI	Same
	Intended Bodypart	WholeBody	WholeBody	Same
	Automatic Stitching	Yes	Yes	Same
	Manual Stitching	Yes	Yes	Same
	HomogenousModification	Yes	Yes	Same
	Sharp/Smooth	Yes	Yes	Same
	Save Image Data	Yes	Yes	Same
	Print Image Data	Yes	Yes	Same
	Report	Yes	Yes	Same

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Image /page/9/Picture/1 description: The image shows 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 words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and it is likely used to represent the company's brand.

Application	Function name	ProposeddeviceuWS-MR	Reference Device#2syngo.MR General,syngo.MRCardiology andsyngo.MR Vascular(K130749)	ReferenceDevice#7AWSERVER(K081985)	Remark
MR VesselAnalysis	Type of imagingscans	MRI	MRI	/	Same
	Intended Bodypart	WholeBody	WholeBody	/	Same
	Automatic bloodvessel center linesextraction	Yes	Yes	/	Same
	Vascular stenosisanalysis:	Yes	/	Yes	Same
	Vascular displaywithMPR\CPR\VR\MIP	Yes	Yes	/	Same
	Save Image Data	Yes	Yes	/	Same
	Print Image Data	Yes	Yes	/	Same
	Report	Yes	Yes	/	Same

Application	Function name	Proposeddevice	Reference Device#3syngo.MR Spectroscopy	Remark
		uWS-MR	(K120315)
MRS	Type of imaging scans	MRI	MRI	Same
	Intended Body part	Brain	Brain	Same
	Single-voxel Spectrum Data Analysis	Yes	Yes	Same
	Chemical Shift Imaging Data	Yes	Yes	Same
	Protocol Management:	Yes	Yes	Same
	Statistics Analysis	Yes	Yes	Same
	Metabolite Pseudo-color Map:	Yes	Yes	Same
	Curve Peak Setting	Yes	Yes	Same
	Save Image Data	Yes	Yes	Same
	Print Image Data	Yes	Yes	Same
	Report	Yes	Yes	Same
		uWS-MR	AdvantageWindowswithFuncToolOption(K960265)
MR	ADC and eADC Calculate	Yes	Yes	Same
Dynamic	T1, T2, T2/R2 Calculate	Yes	Yes	Same
MR MAPS	Background Removal	Yes	Yes	Same
	ROI Curves Analysis: Plot interested region,including correlated or non-correlated,symmetric or asymmetric, and get mean time-intensity curve	Yes	Yes	Same
	Statistic Table: Produce statistical table forparameters, and freely select to display itemsin demand.	Yes	Yes	Same
	DCE (Dynamic Contrast Enhance)customizes background pixel rangecalculation (Support to modify manually), andautomatically provides parameter value, end-stage scanning value (Support to modify byneed). The relative Parameter Maps includesPEI (Positive Enhanced Integration), TTP(Time to Peak), MSI (Maximum Slope ofIncreasing) and MTE (Mean Time toEnhance).	Yes	Yes	Same
	DSC (Dynamic Susceptibility Contrast-enhance) customizes background pixel rangecalculation (Support to modify manually), andautomatically provides parameter value, end-stage scanning value (Support to modify byneed). The relative Parameter Maps includesNEI (Negative Enhanced Integration), TTP(Time to Peak), MSD (Maximum Slop ofDescending) and MTE (Mean Time toEnhance)	Yes	Yes	Same
	Save Image Data	Yes	Yes	Same
	Print Image Data	Yes	Yes	Same
	Report	Yes	Yes	Same

Application	Function name	Proposed device	Reference Device#5	Remark
-------------	---------------	-----------------	--------------------	--------

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Image /page/10/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" symbol, which is made up of two vertical bars and a horizontal bar in the middle.

9. Performance Data

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

SECTION 2 - 9 of 11

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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 For MR Dynamic
Performance Evaluation For MR Breast
Performance Evaluation For MR Stitching
Performance Evaluation For MR Brain Perfusion
. Performance Evaluation For MR Spectroscopy
. Performance Evaluation For MR Fusion
. Performance Evaluation For MR Inner View
Performance Evaluation For MR Vessel
. Performance Evaluation For MR Maps

Product 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).

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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-MR 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).