uOmnispace.MR

K233186 · Shanghai United Imaging Healthcare Co., Ltd. · QIH · Apr 17, 2024 · Radiology

Device Facts

• Record ID: K233186
• Device Name: uOmnispace.MR
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: QIH · Radiology
• Decision Date: Apr 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

uOmnispace.MR is a software solution intended to be used for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications: The uOmnispace.MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages. The uOmnispace.MR Dynamic application is intended to provide a general postprocessing tool for time course studies. The uOmnispace.MR 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 uOmnispace.MR 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 uOmnispace.MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images. The uOmnispace.MR Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets. The uOmnispace.MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images. The uOmnispace.MR DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. The uOmnispace.MR United Neuro is intended to view, manipulate, and evaluate MR neurological images. The uOmnispace.MR Cardiac Function is intended to view, evaluate functional analysis of cardiac MR images. The uOmnispace.MR Flow Analysis is intended to view, evaluate flow analysis of flow MR images.

Device Story

uOmnispace.MR is a post-processing software platform for MR images; runs standalone or with other applications. Inputs: MR volume data sets, time-course studies, spectroscopy data, dynamic contrast-enhanced images, vascular images, neurological images, cardiac MR images. Transforms inputs via various modules: stitching, parametric mapping, segmentation, TIC analysis, flow analysis, and AI-based ventricular segmentation. Outputs: processed images, parameter maps, flow curves, statistical tables, and reports. Used in clinical settings by healthcare professionals for interpretation and evaluation. Benefits: provides tools for quantitative and qualitative analysis of complex MR data, aiding clinical diagnosis and decision-making.

Clinical Evidence

No clinical study required. Bench testing only. Performance evaluation of algorithms (SER, T1rho, semi-automatic contouring, pressure gradients) confirmed acceptable results. AI-based ventricular segmentation validated on 114 patient samples (diverse age, gender, ethnicity, and magnetic field strength) comparing results to predicate device; achieved Sørensen-Dice coefficient of 1.00, demonstrating high consistency.

Technological Characteristics

Standalone software for medical image management and processing. Operates on the uOmnispace platform. Features include rule-based processing and deep learning-based AI algorithms for cardiac segmentation. Connectivity via DICOM standards. No hardware components; biocompatibility and electrical safety not applicable.

Indications for Use

Indicated for viewing, manipulating, evaluating, and analyzing medical images in healthcare institutions. Supports MR image post-processing including stitching, dynamic time-course studies, spectroscopy (SVS/CSI), arithmetic/statistical mapping, breast evaluation, brain perfusion, vessel analysis, DCE analysis, neurological imaging, cardiac function, and flow 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 (K192601)

Reference Devices

• uMR Omega with uWS-MR-MRS (K220332)
• cvi42 (K141480)
• uMR Omega (K230152)
• READY View (K113456)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Shanghai United Imaging Healthcare Co., Ltd. Gao Xin Official Correspondent No. 2258 Chengbei Road. Jiading District Shanghai. 201807 China

Re: K233186

Trade/Device Name: uOmnispace.MR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 7, 2024 Received: March 7, 2024

Dear Gao Xin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

April 17th, 2024

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Ningzhi Li-S

for

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

Submission Number (if known)

K233186

Device Name

uOmnispace.MR

Indications for Use (Describe)

uOmnispace.MR is a software solution intended to be used for viewing, manipulating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

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

The uOmnispace.MR Dynamic application is intended to provide a general postprocessing tool for time course studies.

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

The uOmnispace.MR Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.

· MR uOmnispace.MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images.

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

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

■ The uOmnispace.MR Cardiac Function is intended to view, evaluate functional analysis of cardiac MR images.

The uOmnispace.MR Flow Analysis is intended to view, evaluate flow analysis of flow MR images.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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" 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, and the use of a bold font gives it a strong and confident look.

# 510 (k) SUMMARY

K233186

- 1. Date of Preparation: September 26, 2023
# 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: [phone]-5386 Fax: [phone] Email: [e-mail]

# 3. Identification of Proposed Device

Trade Name: Medical Image Post-processing Software Common Name: Medical image management and processing system Model(s): uOmnispace.MR

Regulatory Information Classification Name: Medical image management and processing system Classification: II Product Code: QIH Regulation Number: 21 CFR 892.2050 Review Panel: Radiology

# 4. Identification of Predicate Device(s)

| Device Classification Name | Medical image management and processing system |
|----------------------------|------------------------------------------------|
| 510(K) Number | K192601 |
| Device Name | uWS-MR |
| Manufacturer | Shanghai United Imaging Healthcare Co., Ltd. |
| Regulation Number | 21 CFR 892.2050 |

#### Predicate Device

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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. To the right of the text is a stylized icon that resembles a shield with a horizontal line through the middle.

| Classification Product Code | QIH |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | Class II |
| Classification Panel | Radiology |
| Intended use | uWS-MR is a software solution intended to be used for<br>viewing, manipulation, communication, and storage of<br>medical images. It supports interpretation and<br>evaluation of examinations within healthcare<br>institutions. |

## Reference Device #1

| Device Classification Name | Magnetic resonance diagnostic device |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K220332 |
| Device Name | uMR Omega with uWS-MR-MRS |
| Manufacturer | Shanghai United Imaging Healthcare Co., Ltd. |
| Regulation Number | 21 CFR 892.1000 |
| Classification Product Code | LNH |
| Device Classification | Class II |
| Classification Panel | Radiology |
| Intended use | uWS-MR is a software solution intended to be used for<br>viewing, manipulation, communication, and storage of<br>medical images. It supports interpretation and<br>evaluation of examinations within healthcare<br>institutions. |

## Reference Device #2

| Device Classification Name | Picture Archiving and Communications System |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K141480 |
| Device Name | cvi42 |
| Manufacturer | Circle Cardiovascular Imaging Inc |
| Regulation Number | 21 CFR 892.2050 |
| Classification Product Code | LLZ |
| Device Classification | Class II |
| Classification Panel | Radiology |
| Intended use | cvi 42 vascular add-on is software application for<br>evaluating cardiovascular images in a DICOM Standard<br>format. cvi 42 has a graphical user interface which<br>allows users to qualitatively and quantitatively analyze<br>cardiac CT & MR images. |

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is divided vertically into two halves with a horizontal line connecting the two halves at the top.

## Reference Device #3

| Device Classification Name | Magnetic resonance diagnostic device |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K230152 |
| Device Name | uMR Omega |
| Manufacturer | Shanghai United Imaging Healthcare Co., Ltd. |
| Regulation Number | 21 CFR 892.1000 |
| Classification Product Code | LNH |
| Device Classification | Class II |
| Classification Panel | Radiology |
| Intended use | The uMR Omega system is indicated for use as a<br>magnetic resonance diagnostic device (MRDD) that<br>produces sagittal, transverse, coronal, and oblique cross<br>sectional images, and spectroscopic images, and that<br>display internal anatomical structure and/or function of<br>the head, body and extremities. |

## Reference Device #4

| Device Classification Name | Picture archiving and communication system |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K113456 |
| Device Name | READY View |
| Manufacturer | GE Healthcare |
| Regulation Number | 21 CFR 892.2050 |
| Classification Product Code | LLZ |
| Device Classification | Class II |
| Classification Panel | Radiology |
| Intended use | READY View is a image analysis software that allows<br>the user to process dynamic or functional volumetric<br>data and to generate maps that display changes in image<br>intensity aver time, echo time, lb-vague (Diffusion<br>imaging) and frequency (Spectroscopy). The<br>combination of acquired images, reconstructed images,<br>calculated parametric images, tissue segmentation,<br>annotations and measurement performed by the clinician<br>allows multi-parametric analysis and may provide<br>clinically relevant information for diagnosis. |

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Image /page/6/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", both in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold, sans-serif font. The color of the logo is a dark gray or charcoal color.

# 5. Device Description

The uOmnispace.MR is a post-processing software based on the uOmnispace platform (cleared in K230039) for viewing, manipulating, evaluating and analyzing MR images, can run alone or with other advanced commercially cleared applications.

This proposed device contains the following applications:

- uOmnispace.MR Stitching
- uOmnispace.MR Dynamic
- uOmnispace.MR MRS
- uOmnispace.MR MAPs
- uOmnispace.MR Breast Evaluation
- . uOmnispace.MR Brain Perfusion
- uOmnispace.MR Vessel Analysis
- uOmnispace.MR DCE Analysis
- uOmnispace.MR United Neuro
- uOmnispace.MR Cardiac Analysis
- uOmnispace.MR Flow Analysis

# 6. Indications for use

uOmnispace.MR is a software solution intended to be used for viewing, manipulating, evaluating and analyzing medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

- . The uOmnispace.MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
- . The uOmnispace.MR Dynamic application is intended to provide a general postprocessing tool for time course studies.
- . The uOmnispace.MR 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 uOmnispace.MR 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.

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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 IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray and has a white line running vertically through the center, creating a negative space effect.

- . The uOmnispace.MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced time-course images.
- . The uOmnispace.MR Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets.
- . The uOmnispace.MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images.
- . The uOmnispace.MR DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.
- . The uOmnispace.MR United Neuro is intended to view, manipulate, and evaluate MR neurological images.
- . The uOmnispace.MR Cardiac Function is intended to view, evaluate functional analysis of cardiac MR images.
- . The uOmnispace.MR Flow Analysis is intended to view, evaluate flow analysis of flow MR images

# 7. Summary of Technological Characteristics

The technology characteristics of uOmnispace.MR, reflected in this 510(k) submission are substantially equivalent to those of the predicate devices.

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

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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 text is a stylized "U" shape, which is formed by two vertical lines connected by a horizontal line in the middle. The logo is simple and modern in design.

| Table 1 Substantial equivalent discussion for basic functions | | | |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Item | Proposed Device | Predicate Device | Remark |
| | uOmnispace.MR | uWS-MR (K192601) | |
| General | | | |
| Device Classification<br>Name | Medical image management and<br>processing system | Medical image management and<br>processing system | Same |
| Product Code | QIH | QIH | 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 | Same |
| Indications for use | uOmnispace.MR is a software solution<br>intended to be used for viewing,<br>manipulating, evaluating and analyzing<br>medical images. It supports interpretation<br>and evaluation of examinations within<br>healthcare institutions. It has the following<br>additional indications:<br>• The uOmnispace.MR Stitching is<br>intended to create full-format images from | uWS-MR is a software solution intended<br>to be used for viewing, manipulation,<br>communication, and storage of medical<br>images. It supports interpretation and<br>evaluation of examinations within<br>healthcare institutions. It has the following<br>additional indications:<br>• The MR Stitching is intended to create<br>full-format images from overlapping | Substantial Equivalent<br>Note 1 |
| | overlapping MR volume data sets acquired<br>at multiple stages. | MR volume data sets acquired at<br>multiple stages. | |
| Item | Proposed Device<br>uOmnispace.MR | Predicate Device<br>uWS-MR (K192601) | Remark |
| • | • The uOmnispace.MR Dynamic<br>application is intended to provide a general<br>post-processing tool for time course<br>studies. | • The Dynamic application is intended<br>to provide a general post-processing<br>tool for time course studies. | |
| • | • The uOmnispace.MR MRS (MR<br>Spectroscopy) is intended to evaluate the<br>molecule constitution and spatial<br>distribution of cell metabolism. It provides<br>a set of tools to view, process, and analyze<br>the complex MRS data. This application<br>supports the analysis for both SVS (Single<br>Voxel Spectroscopy) and CSI (Chemical<br>Shift Imaging) data. | • MRS (MR Spectroscopy) is intended<br>to evaluate the molecule constitution<br>and spatial distribution of cell<br>metabolism. It provides a set of tools<br>to view, process, and analyze the<br>complex MRS data. This application<br>supports the analysis for both SVS<br>(Single Voxel Spectroscopy) and CSI<br>(Chemical Shift Imaging) data. | |
| • | • The uOmnispace.MR MAPS<br>application is intended to provide a number<br>of arithmetic and statistical functions for<br>evaluating dynamic processes and images.<br>These 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 uOmnispace.MR Breast<br>Evaluation application provides the user a | • The MR Breast Evaluation application<br>provides the user a tool to calculate | |
| Item | Proposed Device | Predicate Device | Remark |
| | uOmnispace.MR | uWS-MR (K192601) | |
| | tool to calculate parameter maps from contrast-enhanced time-course images. | parameter maps from contrast-enhanced time-course images. | |
| | The uOmnispace.MR Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets. | The Brain Perfusion application is intended to allow the visualization of temporal variations in the dynamic susceptibility time series of MR datasets. | |
| | The uOmnispace.MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images. | MR Vessel Analysis is intended to provide a tool for viewing, manipulating, and evaluating MR vascular images. | |
| | The uOmnispace.MR DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. | The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images. | |
| | The uOmnispace.MR United Neuro is intended to view, manipulate, and evaluate MR neurological images. | The United Neuro is intended to view, manipulate, and evaluate MR neurological images. | |
| | The uOmnispace.MR Cardiac Function is intended to view, evaluate functional analysis of cardiac MR images. | The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative | |
| Item | Proposed Device | Predicate Device | Remark |
| | uOmnispace.MR | uWS-MR (K192601) | |
| | • The uOmnispace.MR Flow<br>Analysis is intended to view, evaluate flow<br>analysis of flow MR images. | evaluation of cardiac magnetic<br>resonance data. | |

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Image /page/9/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 "U" shape, which is also in a bold font. The color of the text and the "U" shape is a dark teal.

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Image /page/10/Picture/1 description: The image shows 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, dark teal-colored icon that resembles the letter "U" with a vertical white line running through the center, creating a negative space "I" shape.

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Image /page/11/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 text is a stylized "U" shape, which is dark teal in color with a white line running vertically through the center.

#### Table 2 Substantial equivalent discussion for Advanced Applications

| Application | Function name | Proposed<br>device<br>uOmnispace.MR | Predicate<br>Device<br>uWS-MR<br>(K192601) | Reference<br>Device#1<br>uMR<br>Omega<br>with uWS-<br>MR-MRS<br>(K220332) | Reference<br>Device#2<br>cvi42<br>(K141480) | Reference<br>Device#3<br>uMR<br>Omega<br>(K230152) | Reference<br>Device#4<br>READY<br>View<br>(K113456) | Remark |
|------------------------|----------------------------------------------------|-------------------------------------|--------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------|-----------------------------------------------------|-------------------------------------|
| MR DCE<br>Analysis | Motion Correction | Yes | Yes | / | / | / | / | Same |
| | Series Registration | Yes | Yes | / | / | / | / | Same |
| | Parametric Maps | Yes | Yes | / | / | / | / | Same |
| | ROI Analysis | Yes | Yes | / | / | / | / | Same |
| | Save, Filming and<br>Report | Yes | Yes | / | / | / | / | Same |
| MR Brain<br>Perfusion | Motion Correction | Yes | Yes | / | / | / | / | Same |
| | Background<br>Removal | Yes | Yes | / | / | / | / | Same |
| | | | | | | | | |
| | Define Arterial Input Function<br>(AIF) | Yes | Yes | / | / | / | / | Same |
| | Parametric Mapping Calculation | Yes | Yes | / | / | / | / | Same |
| | TIC Analysis | Yes | Yes | / | / | / | / | Same |
| | Save, Filming and Report | Yes | Yes | / | / | / | / | Same |
| MR Breast Evaluation | Automatic Subtraction | Yes | Yes | / | / | / | / | Same |
| | Motion Correction | Yes | Yes | / | / | / | / | Same |
| | TIC Analysis | Yes | Yes | / | / | / | / | Same |
| | Background Removal | Yes | Yes | / | / | / | / | Same |
| | Parameter Map Calculation:WO, WI, TTP, PEI and MSI | Yes | Yes | / | / | / | / | Same |
| | Parameter Map Calculation: SER | Yes | / | / | / | / | Yes | Same |
| | Save, Filming and Report | Yes | Yes | / | / | / | / | Same |
| MR<br>Stitching | Automatic Stitching | Yes | Yes | / | / | / | / | Same |
| | | | | | | | | |
| | Manual Stitching | Yes | Yes | / | / | / | / | Same |
| | Normalization | Yes | Yes | / | / | / | / | Same |
| | Sharp/Smooth | Yes | Yes | / | / | / | / | Same |
| | Save, Filming and<br>Report | Yes | Yes | / | / | / | / | Same |
| MR Vessel<br>Analysis | Automatic<br>Centerline<br>Extraction | Yes | Yes | / | / | / | / | Same |
| | Vascular Stenosis<br>Analysis | Yes | Yes | / | / | / | / | Same |
| | Optimized<br>Vascular<br>Displaying | Yes | Yes | / | / | / | / | Same |
| | Save, Filming and<br>Report | Yes | Yes | / | / | / | / | Same |
| MR<br>Dynamic | Background<br>Removal | Yes | Yes | / | / | / | / | Same |
| | Motion Correction | Yes | Yes | / | / | / | / | Same |
| | TIC Analysis | Yes | Yes | / | / | / | / | Same |
| | Statistic Table | Yes | Yes | / | / | / | / | Same |
| | DCE and DSC<br>Analysis | Yes | Yes | / | / | / | / | Same |
| | Save, Filming and<br>Report | Yes | Yes | / | / | / | / | Same |
| MR MAPs | Background<br>Removal | Yes | Yes | / | / | / | / | Same |
| | T1, T2/R2,<br>T2*/R2* | Yes | Yes | / | / | Yes | / | Same |
| | T1rho Calculation | Yes | / | / | / | Yes | / | Same |
| | ADC and eADC<br>Calculation | Yes | Yes | / | / | / | / | Same |
| | TIC Analysis | Yes | Yes | / | / | / | / | Same |
| | Statistic Table | Yes | Yes | / | / | / | / | Same |
| | Save, Filming and<br>Report | Yes | Yes | / | / | / | / | Same |
| MR United<br>Neuro | Motion Correction | Yes | Yes | / | / | / | / | Same |
| | Functional<br>Activation<br>Calculation | Yes | Yes | / | / | / | / | Same |
| | Diffusion<br>Parameter<br>Analysis | Yes | Yes | / | / | / | / | Same |
| | Adjust Display<br>Parameter | Yes | Yes | / | / | / | / | Same |
| | Fusion | Yes | Yes | / | / | / | / | Same |
| | Fiber Tracking | Yes | Yes | / | / | / | / | Same |
| | Time-Intensity<br>Curve | Yes | Yes | / | / | / | / | Same |
| | ROI Analysis | Yes | Yes | / | / | / | / | Same |
| | MR Segmentation | Yes | Yes | / | / | / | / | Same |
| | Save, Filming and<br>Report | Yes | Yes | / | / | / | / | Same |
| MR Cardiac<br>Function | LV&RV Contour<br>Segmentation | Yes | Yes | / | / | / | / | Same |
| | LAX Extent<br>Definition | Yes | Yes | /…