uMR Omega with uWS-MR-MRS

K220332 · Shanghai United Imaging Healthcare Co., Ltd. · LNH · Oct 27, 2022 · Radiology

Device Facts

• Record ID: K220332
• Device Name: uMR Omega with uWS-MR-MRS
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: Oct 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan. 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

uMR Omega is a 3.0T superconducting MRI system with a 75cm bore; inputs include RF signals captured via various coils (Head/Neck, Spine, Body, etc.) and patient vital signals (ECG, respiratory). The system transforms these signals into anatomical and functional images using pulse sequences and reconstruction methods, including AI-assisted Compressed Sensing and DeepRecon. Operated by clinicians in healthcare settings, the system provides images and derived parameters via the uWS-MR software suite. Output is used by physicians for diagnostic interpretation. Benefits include high-resolution imaging, automated slice positioning (EasyScan), and advanced quantitative analysis (e.g., spectroscopy, perfusion, cardiac mapping). The system supports remote assistance and MR-conditional implant modes.

Clinical Evidence

Bench testing and performance evaluation only. DeepRecon algorithm validated on 77 US subjects (diverse demographics) and compared against non-DeepRecon (NADR) images. Metrics included SNR (302.48 vs 209.41), uniformity (0.15% difference), and contrast (0.9% difference). Radiologist evaluation confirmed diagnostic quality equivalent or superior to standard images. No clinical prospective/retrospective patient outcome studies provided.

Technological Characteristics

3.0T superconducting magnet; 75cm bore; 45mT/m gradient amplitude; 200T/m/s slew rate; 2 transmit channels; up to 96 receive channels. Conforms to NEMA and DICOM standards. Patient contact materials tested per ISO 10993-5/10. Software includes AI-based image processing (DeepRecon). Connectivity via DICOM. Sterilization not applicable (non-invasive).

Indications for Use

Indicated for use as a magnetic resonance diagnostic device (MRDD) to produce cross-sectional images (sagittal, transverse, coronal, oblique) and spectroscopic images of the head, body, and extremities to display internal anatomical structure and/or function. For use by trained physicians to assist in diagnosis. Contrast agents may be used.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• uMR Omega (K193200)

Reference Devices

• uWS-MR (K192601)
• uMR 780 (K193176)

Submission Summary (Full Text)

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October 27, 2022

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

Re: K220332

Trade/Device Name: uMR Omega with uWS-MR-MRS Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LLZ, QIH Dated: September 23, 2022 Received: September 26, 2022

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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

Enclosure

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## Indications for Use

510(k) Number (if known) K220332

Device Name uMR Omega, uWS-MR-MRS

#### Indications for Use (Describe)

The uMR Omega system is indicated for use as a magnetic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

u WS-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, 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.

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/4/Picture/1 description: The image shows 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 letter "U" that is also in bold. The logo is simple and modern.

### 510 (k) SUMMARY

### 1. Date of Prepared

October 19, 2022

K220332

### 2. Sponsor Identification

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

Contact Person: Xin GAO Position: Regulatory Affairs Specialist Tel: [phone]-5386 Fax: [phone] Email: [e-mail]

### 3. Identification of Proposed Device(s)

Trade Name: uMR Omega with uWS-MR-MRS Common Name: Magnetic Resonance Diagnostic Device Model: uMR Omega, uWS-MR Product Code: LNH, LLZ, QIH Regulation Number: 21 CFR 892.1000 Device Class: II

### 4. Identification of Predicate Devices(s)

Predicate Device 510(k) Number: K193200 Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

## Reference Device #1

510(k) Number: K192601 Device Name: uWS-MR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: II Product Code: LLZ, OIH

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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 a bold, sans-serif font, stacked on top of each other. 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.

### Reference Device #2

510(k) Number: K193176 Device Name: uMR 780 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

## 5. Device Description

The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

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.

The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm size patient bore. It consists of components such as magnet, RF power amplifier. RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

uMR Omega , uWS-MR and uMR 780 have been previously cleared by FDA via K193200 , K192601 and K193176.

The modification performed on the uMR Omega (K193200). uWS-MR (K192601) and uMR 780 (K193176) in this submission is due to the following changes that include: (1). Addition of Radio Frequency Coils: Head & Neck Coil - 48, Spine Coil - 48, Head Coil - 64, SuperFlex Body - 24, SuperFlex Large - 12, SuperFlex Small -12. (2). Addition and modification of pulse sequences

a) New sequences: gre_fact, asl_3d, gre_maps, fse_mars_sle, grase, fse_dwi, fse arms dwi, gre fq, gre bssfp fi, epi dwi msh, gre senc spiral, gre bssfp ucs, gre_rufis.

b) Broadened application scope of Contrast characteristic for certain sequences: T1 mapping, T2 mapping, T2* mapping.

c) Added Associated options for certain sequences: QuietScan, Parallel imaging, MultiBand, Inversion Recovery.

d) Added Reconstruction method for certain sequences: AI-assisted Compressed Sensing, Compressed sensing.

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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" symbol, which is also in a bold font. The logo is simple and modern.

e) Added Additional accessory equipment required for certain sequences: respiratory, cardiac gating.

f) Deletion of pulse sequence: fse mx mars.

(3). Addition of Imaging processing methods: Fat Analysis and Calculation Technique (FACT), Inline T1/T2* Map, Inline T2 Map, Arterial Spin Labeling (ASL), Flow Quantification (FQ), Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping, DeepRecon.

(4). Addition of Spectroscopy Sequences and Post Processing Features: Liver, Prostate, Breast.

(5). Addition of New function: Remote Assistance, MR conditional implant mode. (6). Addition of Support body parts for EasyScan: Shoulder, Abdomen, L-spine, Tspine.

These modifications do not affect the intended use or alter the fundamental scientific technology of the device.

## 6. Intended Use

The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

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.
- A 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.

## Page 3 of 16

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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, also in a bold font. The logo is simple and modern in design.

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

The uMR 780 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.

These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.

## 7. Technological Characteristic

The differences from the predicate device are discussed in the comparison table in this submission is added below.

| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR Omega (K193200) | Remark |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| Indications For<br>Use | The uMR Omega system is<br>indicated for use as a<br>magnetic<br>resonance<br>diagnostic device (MRDD) that<br>produces sagittal,<br>transverse, coronal, and<br>oblique cross sectional<br>images, and spectroscopic | The uMR Omega<br>system is indicated for<br>use as a magnetic<br>resonance diagnostic<br>device (MRDD) that<br>produces sagittal,<br>transverse, coronal, and<br>oblique cross sectional | Same |
| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR Omega (K193200) | Remark |
| | images, and that display<br>internal anatomical<br>structure and/or function of<br>the head, body and<br>extremities.<br>These images and the<br>physical parameters<br>derived from the images<br>when interpreted by a<br>trained physician yield<br>information that may<br>assist the diagnosis.<br>Contrast agents may be<br>used depending on the<br>region of interest of the<br>scan. | images, and<br>spectroscopic images,<br>and that display internal<br>anatomical structure<br>and/or function of the<br>head, body and<br>extremities.<br>These images and the<br>physical parameters<br>derived from the<br>images when<br>interpreted by a trained<br>physician yield<br>information that may<br>assist the diagnosis.<br>Contrast agents may be<br>used depending on the<br>region of interest of the<br>scan. | |
| Magnet system | | | |
| Field Strength | 3.0 Tesla | 3.0 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-<br>accessible bore<br>dimensions | 75cm | 75cm | Same |
| Type of<br>Shielding | Actively shielded, OIS<br>technology | Actively shielded, OIS<br>technology | Same |
| Magnet<br>Homogeneity | 2.30ppm @ 50cm DSV<br>0.80ppm @ 45cm DSV<br>0.38ppm @ 40cm DSV<br>0.08ppm @ 30cm DSV<br>0.02ppm @ 20cm DSV<br>0.002ppm @ 10cm DSV | 2.30ppm @ 50cm DSV<br>0.80ppm @ 45cm DSV<br>0.38ppm @ 40cm DSV<br>0.08ppm @ 30cm DSV<br>0.02ppm @ 20cm DSV<br>0.002ppm @ 10cm<br>DSV | Same |
| Gradient system | | | |
| Max gradient<br>amplitude | 45mT/m | 45mT/m | Same |
| Max slew rate | 200T/m/s | 200T/m/s | Same |
| Shielding | active | active | Same |
| Cooling | water | water | Same |
| RF system | | | |
| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR Omega (K193200) | Remark |
| Resonant<br>frequencies | 128.23 MHz | 128.23 MHz | Same |
| Number of<br>transmit<br>channels | 2 | 2 | Same |
| Number of<br>receive channels | Up to 96 | Up to 96 | Same |
| Amplifier peak<br>power per<br>channel | 18 kW | 18 kW | Same |
| <b>RF Coils</b> | | | |
| Volume<br>Transmit Coil | Yes | Yes | Same |
| Head & Neck<br>Coil -24 | Yes | Yes | Same |
| Body Array Coil<br>- 12 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Flex Coil Large -<br>8 | Yes | Yes | Same |
| Flex Coil Small -<br>8 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower Extremity<br>Coil - 36 | Yes | Yes | Same |
| Shoulder Coil -<br>12 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Spine Coil - 32 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Cardiac Coil -<br>24 | Yes | Yes | Same |
| Temporomandib<br>ular Joint Coil -<br>4 | Yes | Yes | Same |
| Foot & Ankle<br>Coil - 24 | Yes | Yes | Same |
| Head Coil - 32 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Infant Coil - 24 | Yes | Yes | Same |
| Body Array Coil<br>- 24 | Yes | Yes | Same |
| ITEM | Proposed Device<br>uMR Omega…