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.

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.

The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.

The United Neuro is intended to view, manipulate, and evaluate MR neurological images.

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.

This subject device contains the following modifications/improvements in comparison to the predicate device uWS-MR:

Modified Indications for Use Statement;
Added some advanced applications:

DCE Analysis
United Neuro

AI/ML Overview

The provided text from the FDA 510(k) summary (K183164) for uWS-MR describes a software solution primarily for viewing, manipulation, and storage of medical images, with added advanced applications such as DCE Analysis and United Neuro. However, the document does not provide specific acceptance criteria or detailed study data to prove the device meets those criteria in the typical format of a clinical performance study.

The submission is for a modification to an existing device (uWS-MR, K172999) by adding two new features: DCE Analysis and United Neuro. The "study" described is primarily a performance verification demonstrating that these new features function as intended and are substantially equivalent to previously cleared reference devices with similar functionalities.

Here's a breakdown of the requested information based on the provided document, noting where specific details are absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a table of reported device performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI-driven diagnostic device. Instead, the "performance" is assessed through verification that the new features (DCE Analysis and United Neuro) operate comparably to predicate devices and meet functional and safety standards.

The comparison tables (Table 2 for DCE Analysis and the subsequent table for United Neuro) serve as a substitute for performance criteria by demonstrating functional equivalence to reference devices.

Implicit Acceptance Criteria (based on comparison to reference devices): The new functionalities (DCE Analysis and United Neuro) must exhibit the same core operational features (e.g., image loading, viewing, motion correction, parametric maps, ROI analysis, result saving, reporting for DCE; and motion correction, functional activation calculation, diffusion parameter analysis, display adjustment, fusion, fiber tracking, time-intensity curve, ROI statistics, result saving, reporting for United Neuro) as their respective predicate/reference devices.

Reported Device Performance (Functional Equivalence):
The document states that the proposed device's functionalities are "Same" or "Yes" compared to the reference devices for all listed operational features, implying that they perform equivalently in terms of available functions.

Application	Function Name	Proposed Device (uWS-MR)	Reference Device Comparison	Remark (from document)
DCE Analysis	Type of imaging scans	MR	MR	Same
	Image Loading and Viewing	Yes	Yes	Same
	Motion Correction	Yes	Yes	Same
	Series Registration	Yes	Yes	Same
	Parametric Maps (Ktrans, kep, ve, vp, iAUC, Max Slop, CER)	Yes (for all)	Yes (for most)	Same (for most, / for others but implied functional)
	ROI Analysis	Yes	Yes	/ (Implied Same)
	Result Saving	Yes	Yes	Same
	Report	Yes	Yes	Same
United Neuro	Type of imaging scan	MR	MR	Same
	Motion correction	Yes	Yes	Same
	Functional activation calculation	Yes	Yes	Same
	Diffusion parameter analysis	Yes	Yes	Same
	Adjust display parameter	Yes	Yes	Same
	Fusion	Yes	Yes	Same
	Fiber tracking	Yes	Yes	Same
	Time-Intensity curve	Yes	Yes	Same
	ROI Statistics	Yes	Yes	Same
	Result Saving	Yes	Yes	Same
	Report	Yes	Yes	Same

(Note: The document uses "/" in some rows for reference devices, which generally means the feature wasn't applicable or explicitly listed for that device, but the "Remark" column still concludes "Same" or "Yes," implying that the proposed device's functionality is considered equivalent or non-inferior within the context of substantial equivalence.)

Study Details:

Sample sizes used for the test set and the data provenance:
The document mentions "Performance Evaluation Report For MR DCE" and "Performance Evaluation Report For MR United neuro" as part of the "Performance Verification." However, it does not specify any sample sizes (number of cases or images) used for these performance evaluations. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide any information regarding the number or qualifications of experts used for establishing ground truth, as it's a software verification and validation rather than a clinical reader study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Since no reader study or expert review for ground truth establishment is described, there's no mention of an adjudication method.
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 MRMC comparative effectiveness study was reported or required. The submission is for a software post-processing tool, not an AI-assisted diagnostic tool that directly impacts human reader performance or diagnosis.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance verification for the new features (DCE Analysis and United Neuro) can be considered a form of standalone testing, as it demonstrates the algorithms' functional capabilities and outputs. However, the document doesn't provide quantitative metrics like accuracy, sensitivity, or specificity for these algorithms. It focuses on functional equivalence to existing cleared devices rather than a standalone performance benchmark against a clinical ground truth.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not specify the type of "ground truth" used for the performance verification of the DCE Analysis and United Neuro features. Given the nature of a 510(k) for a post-processing software with added functionalities, the "ground truth" likely refers to the expected algorithmic output or behavior as defined by engineering specifications and comparison to the outputs of the predicate/reference devices, rather than a clinical ground truth derived from expert consensus, pathology, or outcomes for disease detection.
The sample size for the training set:
The document does not mention any training set size. This is because the device is described as "MR Image Post-Processing Software" and its functionalities seem to be based on established image processing algorithms rather than a machine learning model that requires a distinct training phase.
How the ground truth for the training set was established:
As no training set is mentioned for a machine learning model, this information is not applicable/not provided.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO.2258 Chengbei Road, Jiading District Shanghai, 201807 CHINA

Re: K183164

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: March 14, 2019 Received: March 18, 2019

Dear Xin Gao:

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 mav, 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 avare 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/cfpmn/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

March 22, 2019

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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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 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

Thalia Mills, 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) K183164

Device Name uWS-MR

Indications for Use (Describe)

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.

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.

The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The United Neuro is intended to view, manipulate, and evaluate MR neurological images.

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/2 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 "U" shape, which is also in a bold font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.

510 (k) SUMMARY

1. Date of Preparation: November 12, 2018

2. Sponsor Identification

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

Establishment Registration Number: 3011015597

Contact Person: Xin.Gao Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@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: K172999 Device Name: uWS-MR

Reference Device#1 510(k) Number: K133401 Device Name: syngo.MR Neurology, syngo.MR Oncology, syngo.MR BreVis and syngo.mMR General

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Image /page/4/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, which is formed by two vertical lines and a curved bottom line. There is a horizontal line in the middle of the "U" shape, creating a cross-like design within the "U".

Reference Device#2 510(k) Number: K090546 Device Name: Nordic Image Control and Evaluation (nordicICE) Software

Reference Device#3 510(k) Number: K143368 Device Name: GenIQ

Reference Device#4 510(k) Number: K151353 Device Name: syngo.MR Neurology, syngo.MR Oncology

5. Device Description

This subject device contains the following modifications/improvements in comparison to the predicate device uWS-MR:

Modified Indications for Use Statement;
Added some advanced applications:

DCE Analysis .
- . United Neuro

6. Indications for use

. 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.

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is dark blue and has a white line running vertically and horizontally through it.

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.
. The DCE analysis is intended to view, manipulate, and evaluate dynamic contrastenhanced MRI images.
. The United Neuro is intended to view, manipulate, and evaluate MR neurological images

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

Both the subject and predicate device have the same general information, such as Device Classification Name, Product Code, Classification Panel, etc. and visualization and

measurement technological features:

Image communication
Hardware /OS
Patient Administration
Review 2D
Review 3D
Filming
Fusion
Inner View
Visibility

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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 divided into two sections by a horizontal line. The logo is simple and modern, and the use of bold text and a geometric shape makes it easily recognizable.

ROI/VOI
MIP Display
Compare

The subject and predicate device also have the same advanced applications in following:

MR Brain Perfusion ●
MR Breast Evaluation
MR Stitching
MR Vessel Analysis
MRS
MR Dynamic
MR MAPs

The differences between the subject and the predicate device are about advanced applications is as follows:

The subject device has added 2 new features to the predicate device. Substantial equivalence of these 2 features between the subject and the corresponding reference device is also discussed in Chapter 3.
- . DCE Analysis
  - . United Neuro

SECTION 6 - 4 of 11

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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED" stacked on top of "IMAGING" in a bold, sans-serif font. To the right of the text is a stylized graphic element that appears to be a stylized letter "U" or a shield-like shape with a vertical line running through it. The color scheme is a dark teal or blue-gray against a white background.

Item	Proposed DeviceuWS-MR	Predicate DeviceuWS-MR (K172999)	Remark
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
Advanced Application	Yes	Yes	The subjectdevice includesmoreapplications,which isdiscussed in thefollowingsections, than thepredicate device.This differencewill not impactthe safety andeffectiveness ofthe device
Item	Proposed DeviceuWS-MR	Predicate DeviceuWS-MR (K172999)	Remark
Intended Use	uWS-MR is a software solution intended to beused for viewing, manipulation, communication,and storage of medical images. It supportsinterpretation and evaluation of examinationswithin healthcare institutions. It has the followingadditional 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	uWS-MR is a software solution intended to beused for viewing, manipulation, communication,and storage of medical images. It supportsinterpretation and evaluation of examinationswithin healthcare institutions. It has the followingadditional 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	The intended useis supplemented.The subjectdevice includesmoreapplications,which isdiscussed in thefollowingsections. Thisdifference willnot impact thesafety andeffectiveness ofthe device.
Item	Proposed DeviceuWS-MR	Predicate DeviceuWS-MR (K172999)	Remark
	and images. These functions are applied tothe grayscale values of medical images.	applied to the grayscale values of medicalimages.
	● The MR Breast Evaluation applicationprovides the user a tool to calculateparameter maps from contrast-enhancedtime-course images.	● The MR Breast Evaluation applicationprovides the user a tool to calculateparameter maps from contrast-enhancedtime-course images.
	● The Brain Perfusion application is intendedto allow the visualization of temporalvariations in the dynamic susceptibility timeseries of MR datasets.	● The Brain Perfusion application is intendedto allow the visualization of temporalvariations in the dynamic susceptibility timeseries of MR datasets.
	● MR Vessel Analysis is intended to provide atool for viewing, manipulating, andevaluating MR vascular images.	● MR Vessel Analysis is intended to provide atool for viewing, manipulating, andevaluating MR vascular images.
	● The Inner view application is intended toperform a virtual camera view throughhollow structures (cavities), such as vessels.	● The Inner view application is intended toperform a virtual camera view throughhollow structures (cavities), such as vessels.
	● The DCE analysis is intended to view,manipulate, and evaluate dynamic contrast-enhanced MRI images.
	● The United Neuro is intended to view,manipulate, and evaluate MR neurologicalimages.

Table 1 Comparison of general information

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Image /page/8/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 words is a stylized symbol that resembles a capital "U" with a horizontal line through the middle. The logo is simple and modern, and the use of bold font and a clean symbol makes it easily recognizable.

SECTION 6 - 6 of 11

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Image /page/9/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 symbol that appears to be a combination of the letters "U" and "I". The logo is simple and modern, with a focus on the company name and a unique symbol.

SECTION 6 - 7 of 11

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Application	Function name	Proposeddevice	ReferenceDevice#1	ReferenceDevice#2	ReferenceDevice#3	Remark
		uWS-MR	syngro.MR	NordicImage	GenIQ(K143368)
			Tissue4D(K133401)	Control andEvaluation(nordicICE)Software(K090546)
DCEAnalysis	Type of imaging scans	MR	MR	MR	MR	Same
	Image Loading and Viewing	Yes	Yes	Yes	Yes	Same
	Motion Correction	Yes	Yes	/	/	Same
	Series Registration	Yes	Yes	/	/	Same
	Parametric Maps
	.Ktrans	Yes	/	Yes	/	Same
	.kep	Yes	/	Yes	/	Same
	.ve	Yes	/	Yes	/	Same
	.vp	Yes	/	Yes	/	Same
	.iAUC	Yes	/	Yes	/	/
	.Max Slop	Yes	/	/	/	Yes
	.CER	Yes	/	/	/	Yes
	ROI Analysis	Yes	Yes	/	/	/
	Result Saving	Yes	Yes	/	/	Same
	Report	Yes	Yes	/	/	Same

Table 2 SE Discussion for added Advanced Applications

SECTION 6 - 8 of 11

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Application	Function name	ProposeddeviceuWS-MR	Referencedevice#4:Syngo.via(K151353)	Remark
United Neuro	Type of imaging scan	MR	MR	Same
	Motion correction	Yes	Yes	Same
	Functional activation calculation	Yes	Yes	Same
	Diffusion parameter analysis	Yes	Yes	Same
	Adjust display parameter	Yes	Yes	Same
	Fusion	Yes	Yes	Same
	Fiber tracking	Yes	Yes	Same
	Time-Intensity curve	Yes	Yes	Same
	ROI Statistics	Yes	Yes	Same
	Result Saving	Yes	Yes	Same
	Report	Yes	Yes	Same

SECTION 6 - 9 of 11

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Shanghai United Imaging Healthcare Co., Ltd Tel: +86 (21) 67076888 Fax : +86 (21) 67076889 www.united-imaging.com

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 MR DCE
. Performance Evaluation Report For MR United neuro

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).
IEC 62304 Medical device software - Software life cycle processes (Edition 1.1, 2015).

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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.

SECTION 6 - 11 of 11

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).