uWS-MR

K192601 · Shanghai United Imaging Healthcare Co., Ltd. · QIH · Jun 1, 2020 · Radiology

Device Facts

• Record ID: K192601
• Device Name: uWS-MR
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: QIH · Radiology
• Decision Date: Jun 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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. 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. The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data.

Device Story

uWS-MR is a software solution for viewing, processing, and analyzing MR images; functions as stand-alone SaMD or post-processing application for UIH MR scanners. Inputs include DICOM 3.0 anatomical and functional MR datasets from network or external storage. Transforms data via various modules: MR Stitching, Dynamic, Image Fusion, MRS, MAPs, Breast Evaluation, Brain Perfusion, Vessel Analysis, Inner View, DCE, United Neuro, and Cardiac Analysis. Outputs include processed images, parameter maps, and statistical reports. Used in clinical settings by trained, licensed physicians to interpret images and statistics for clinical decision-making. Benefits include enhanced visualization and quantitative evaluation of MR data to support diagnostic workflows.

Clinical Evidence

No clinical study was required. Performance verification provided for MR Cardiac Analysis. Bench testing only.

Technological Characteristics

Software-only device; DICOM 3.0 compliant. Implements image processing algorithms for MR data (segmentation, fusion, quantification). Standards: NEMA PS 3.1-3.20 (DICOM), ISO 14971 (Risk Management), IEC 62304 (Software Life Cycle).

Indications for Use

Indicated for viewing, manipulation, communication, and storage of medical images for interpretation and evaluation within healthcare institutions. Supports MR imaging analysis including stitching, dynamic time-course studies, image fusion, spectroscopy (SVS/CSI), arithmetic/statistical mapping, breast evaluation, brain perfusion, vessel analysis, virtual endoscopy (Inner view), DCE analysis, neurological evaluation, and cardiac analysis.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• uWS-MR (K183164)

Reference Devices

• cvi42 (K141480)
• Philips IntelliSpace Cardiovascular (K153022)

Submission Summary (Full Text)

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

June 1, 2020

### Re: K192601

Trade/Device Name: uWS-MR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH, LLZ Dated: April 29, 2020 Received: May 4, 2020

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 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/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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K192601

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 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 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.

The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data.

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 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 symbol that resembles the letter "U" with a vertical line running through the center, creating a negative space "I" shape. The logo is simple and modern in design.

# 510 (k) SUMMARY

- 1. Date of Preparation: April 29, 2020
# 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 Manager Tel: [phone]-5386 Fax: [phone] Email: [e-mail]

# 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: QIH, LLZ Regulation Number: 21 CFR 892.2050 Review Panel: Radiology

# 4. Identification of Predicate Device(s)

Predicate Device 510(k) Number: K183164 Device Name: uWS-MR

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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font, stacked vertically. To the right of the text is a stylized logo consisting of a dark gray letter "U" shape with a vertical line inside, creating a modern and minimalist design.

Reference Device#1 510(k) Number: K141480 Device Name: cvi42

Reference Device#2 510(k) Number: K153022 Device Name: Philips Medical Systems Nederland BV

# 5. Device Description

uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can be used as a stand-alone SaMD or a post processing application option for cleared UIH (Shanghai United Imaging Healthcare Co.,Ltd.) MR Scanners. 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 Traditional 510(k) is to request modification for the cleared Picture archiving and communications system (uWS-MR) which have been cleared by FDA via K183164 on March 22, 2019.

The modifications performed on the uWS-MR (K183164) in this submission are due to the change of the advanced application (United Neuro) and addition of a new advanced application (MR Cardiac Analysis).

### 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.

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Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, dark gray letters. To the right of the words is a stylized letter "U" that is also dark gray. The letter "U" has a white line running vertically through the center of it.

- . 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 contrastenhanced MRI images.
- . The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
- . The MR Cardiac Analysis application is intended to be used for viewing, postprocessing and quantitative evaluation of cardiac magnetic resonance data.

# 7. Summary of Technological Characteristics

The technology characteristics of the modified uWS-MR, reflected in this 510(k) submission, do not alter the scientific technology of the devices and are substantially equivalent to those of the predicate devices.

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

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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in bold, sans-serif font. To the right of the text is a stylized "U" shape, also in bold. The logo appears to be for a company in the imaging industry.

| Item | Table 1 Substantial equivalent discussion for basic functions<br>Proposed Device | Predicate Device | Remark |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | uWS-MR | uWS-MR (K183164) | |
| General | | | |
| Device Classification<br>Name | Picture Archiving and Communications<br>System | Picture Archiving and Communications<br>System | Same |
| Product Code | QIH, 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 proposed<br>device includes<br>more<br>applications,<br>which is<br>discussed in<br>the following<br>chapters, than<br>the predicate<br>device. This<br>difference will<br>not impact the<br>safety and<br>effectiveness<br>of the device |
| Item | Proposed Device | Predicate Device | Remark |
| | uWS-MR | uWS-MR (K183164) | |
| 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:<br>• The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. | 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:<br>• The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. | The indications for use is supplemented. The proposed device includes more applications, which is discussed in the following chapters. This difference will not impact the safety and effectiveness of the device. |
| | • The Dynamic application is intended to provide a general post-processing tool for time course studies. | • 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 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 | • 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 | |
| Item | Proposed Device | Predicate Device | Remark |
| | uWS-MR | uWS-MR (K183164) | |
| | complex MRS data. This application<br>supports the analysis for both SVS<br>(Single Voxel Spectroscopy) and CSI<br>(Chemical Shift Imaging) data. | complex MRS data. This application<br>supports the analysis for both SVS<br>(Single Voxel Spectroscopy) and CSI<br>(Chemical Shift Imaging) data. | |
| | The MAPs application is intended to<br>provide a number of arithmetic and<br>statistical functions for evaluating<br>dynamic processes and images. These<br>functions are applied to the grayscale<br>values of medical images. | The MAPs application is intended to<br>provide a number of arithmetic and<br>statistical functions for evaluating<br>dynamic processes and images. These<br>functions are applied to the grayscale<br>values of medical images. | |
| | The MR Breast Evaluation application<br>provides the user a tool to calculate<br>parameter maps from contrast-<br>enhanced time-course images. | The MR Breast Evaluation application<br>provides the user a tool to calculate<br>parameter maps from contrast-<br>enhanced time-course images. | |
| | The Brain Perfusion application is<br>intended to allow the visualization of<br>temporal variations in the dynamic<br>susceptibility time series of MR<br>datasets. | The Brain Perfusion application is<br>intended to allow the visualization of<br>temporal variations in the dynamic<br>susceptibility time series of MR<br>datasets. | |
| | MR Vessel Analysis is intended to<br>provide a tool for viewing,<br>manipulating, and evaluating MR<br>vascular images. | MR Vessel Analysis is intended to<br>provide a tool for viewing,<br>manipulating, and evaluating MR<br>vascular images. | |
| Item | Proposed Device<br>uWS-MR | Predicate Device<br>uWS-MR (K183164) | Remark |
| | 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. The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data. | 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. | |
| Specification | | | |
| Image communication | Yes | Yes | Same |
| Hardware /OS | Yes | Yes | Same |
| Patient Administration | Yes | Yes | Same |
| Review 2D | Yes | Yes | Same |
| Review 3D | Yes | Yes | Same |
| Filming | Yes | Yes | Same |
| Fusion | Yes | Yes | Same |
| Inner View | Yes | Yes | Same |
| Item | Proposed Device<br>uWS-MR | Predicate Device<br>uWS-MR (K183164) | Remark |
| Visibility | Yes | Yes | Same |
| ROI/VOI | Yes | Yes | Same |
| MIP Display | Yes | Yes | Same |
| Compare | Yes | Yes | Same |
| Report | Yes | Yes | Optimized function which<br>will not impact<br>the safety and<br>effectiveness. |

Table 1 Substantial equivalent discussion for basic functions

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Image /page/7/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, which is dark blue. The logo is simple and modern.

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Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is 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 teal in color. The logo is simple and modern in design.

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Image /page/9/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 words is a stylized "U" symbol, which is dark gray. The logo is simple and modern.

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Image /page/10/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 text is a stylized "U" shape that is dark gray. The logo is simple and modern.

### Table 2 Substantial equivalent discussion for MR Cardiac Analysis

| Advanced<br>Application | Function name | | Proposed device<br>uWS-MR | Reference Device#1<br>cvi42 (K141480) | Remark |
|---------------------------------------|------------------|--------------------------------------|------------------------------------------------------------------------|---------------------------------------|--------|
| Cardiac Analysis<br>(New application) | Cardiac Function | Type of imaging scans | MR | MR | Same |
| | | Image Loading and Viewing | Yes | Yes | Same |
| | | LV Contour Segmentation | Yes | Yes | Same |
| | | RV Contour Segmentation | Yes | Yes | Same |
| | | Extent Definition | Yes | Yes | Same |
| | | Parameters Calculation | Yes | Yes | Same |
| | | BSA standardized | Yes | Yes | Same |
| | | Polar Maps | Yes | Yes | Same |
| | | Volume Curve | Yes | Yes | Same |
| | | Result Saving | Yes | Yes | Same |
| | | Report | Yes | Yes | Same |
| | Function name | Proposed device<br>uWS-MR | Reference Device#2<br>Philips IntelliSpace Cardiovascular<br>(K153022) | Remark | |
| | Flow Analysis | Type of imaging scans | MR | MR | Same |
| | | Image Loading and Viewing | Yes | Yes | Same |
| | | Plot vessel contour | Yes | Yes | Same |
| | | Propagate Contour | Yes | Yes | Same |
| | | Doppler Map | Yes | Yes | Same |
| | | Parameters Calculation | Yes | Yes | Same |
| | | Flow Curve | Yes | Yes | Same |
| | | Result Saving | Yes | Yes | Same |
| | | Report | Yes | Yes | Same |
| Advanced Application | | Function name | Proposed device<br>uWS-MR | Predicate device<br>uWS-MR (K183164) | Remark |
| United Neuro | | Type of imaging scan | MR | MR | Same |
| (Modified Application) | | Motion correction | Yes | Yes | Same |
| | | Functional activation<br>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 |
| | MR Segmentation | Yes | No | Note1 | |

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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING" 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 across the top, creating a cross-like shape within the "U". The color scheme appears to be a dark blue or gray for the text and symbol against a white background.

Notel : Provides the user-identified region segmentation, users can draw the region of interest manually, which does not affect safety and effectiveness.

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Image /page/12/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 the letter "U" with a vertical line running through the center, creating a negative space that suggests the letter "I". The symbol is a solid, dark color, contrasting with the white background.

#### Performance Data 8.

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
- · Device Hazard Analysis
- · Software Requirements Specification (SRS)
- · Software Architecture Design Chart
- · Software Development Environment Description
- · Software Verification and Validation
- · Cybersecurity Documents

# Animal Study

No animal study was required.

# Clinical Studies

No clinical study was required.

# Performance Verification

Performance Evaluation Report for MR Cardiac Analysis

# 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).

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Image /page/13/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is divided into two halves by a vertical white line. The logo is simple and modern, with a focus on the company name and a clean, geometric design.

- 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 and reference devices.

#### Substantially Equivalent (SE) Conclusion 9.

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.