uMR Omega

K230152 · Shanghai United Imaging Healthcare Co., Ltd. · LNH · May 23, 2023 · Radiology

Device Facts

• Record ID: K230152
• Device Name: uMR Omega
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: May 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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.

Device Story

uMR Omega is a 3.0T superconducting MRI system with a 75cm bore. It acquires MR signals via RF coils and gradient coils, processed by a spectrometer and computer system. Modifications include a new RF power amplifier (uXD2201), additional RF coils (Tx/Rx Knee Coil-24, SuperFlex Body Wide-24), new VSM models, and a dockable patient table. It incorporates a camera-based 'uVision' positioning workflow and a Resoundant acoustic driver for MRE. New software features include 4D Flow Quantification, MRE, SNAP, CEST, T1Rho, and FSP+. Used in clinical settings by trained physicians/technicians. Output consists of anatomical and functional MR images and derived physical parameters. These outputs assist physicians in diagnostic decision-making, potentially improving diagnostic accuracy and patient comfort through advanced imaging sequences and streamlined positioning.

Clinical Evidence

Bench testing only. Performance evaluation reports provided for new features including 4D Flow (gre_fq), MRE (epi_se_mre), CEST (fse_mx), T1rho (gre, fse_mx), mPLD ASL, and silica gel imaging. Compliance with electrical safety (ES 60601-1), EMC (IEC 60601-1-2), and MR safety (IEC 60601-2-33) standards confirmed. Biocompatibility testing (ISO 10993-5, 10993-10) demonstrated no cytotoxicity, irritation, or sensitization.

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. Materials tested per ISO 10993. Connectivity via DICOM/NEMA standards. Software includes pulse sequence control and image processing algorithms. Sterilization not applicable (non-invasive).

Indications for Use

Indicated for use as a magnetic resonance diagnostic device (MRDD) to produce cross-sectional images and spectroscopic images of the head, body, and extremities to display internal anatomical structure and/or function. Used 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 (K220332)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 23, 2023

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

Re: K230152

Trade/Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 24, 2023 Received: April 24, 2023

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

{1}------------------------------------------------

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,

D.G.K.

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K230152

Device Name uMR Omega

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 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.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
| <div style="display:flex; align-items:center;"><span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is also in bold. The color of the logo is a dark gray or blue.

### 510 (k) SUMMARY

### 1. Date of Prepared

April 24, 2023

#### 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 Common Name: Magnetic Resonance Diagnostic Device Model: uMR Omega Product Code: LNH Regulation Number: 21 CFR 892.1000 Device Class: II

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

Predicate Device 510(k) Number: K220332 Device Name: uMR Omega 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

{4}------------------------------------------------

Image /page/4/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 dark color, with a vertical line running down the center, creating a unique design element.

standards.

uMR Omega has been previously cleared by FDA via K220332.

The modification performed on the uMR Omega (K220332) in this submission is due to the following changes that include:

- (1) Addition of the Radio Frequency Power Amplifier model: uXD2201.
- (2) Addition of Radio Frequency Coils: Tx/Rx Knee Coil -24 and SuperFlex Body Wide - 24.
- (3) Addition of VSM models: uVWMERP, uMVRX and mmw100.
- (4) Addition and modification of pulse sequences
- New sequences: gre_snap, gre_quick_4dncemra, gre_trass, epi_se_mre, gre_fq. a)
- b) Added Associated options for certain sequences: T1Rho, CEST, FSP+ (eT1, eGM), silica gel imaging, mPLD, whole heart coronary angiography imaging.
- Name change of pulse sequence: gre (old name: gre sp), gre fine (old name: c) gre_bssfp_fi), gre_quick (gre_quick_wfi merge to gre_quick), gre_quick (gre_bloustracking merge to gre_quick).
- (5) Addition of imaging processing methods: 4D Flow Quantification, Magnetic Resonance Elastography (MRE), SNAP, CEST, T1Rho, FSP+.
- (6) Addition of Dockable Patient Table.
- (7) Add the positioning workflow (uVision) with camera.
- (8) Addition of Resoundant Acoustic Driver System for Magnetic Resonance Elastography (MRE).

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.

# 7. Technological Characteristic

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

| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR Omega (K220332) | Remark |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| 510(K) No. | | K220332 | |
| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR Omega (K220332) | Remark |
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| Indications For Use | The uMR Omega system is<br>indicated for use as a magnetic<br>resonance diagnostic device<br>(MRDD) that produces sagittal,<br>transverse, coronal, and oblique<br>cross sectional images, and<br>spectroscopic images, and that<br>display internal anatomical<br>structure and/or function of the<br>head, body and extremities.<br>These images and the physical<br>parameters derived from the<br>images when interpreted by a<br>trained physician yield<br>information that may assist the<br>diagnosis. Contrast agents may<br>be used depending on the region<br>of interest of the scan. | The uMR Omega system is<br>indicated for use as a magnetic<br>resonance diagnostic device<br>(MRDD) that produces sagittal,<br>transverse, coronal, and oblique<br>cross sectional images, and<br>spectroscopic images, and that<br>display internal anatomical<br>structure and/or function of the<br>head, body and extremities.<br>These images and the physical<br>parameters derived from the<br>images when interpreted by a<br>trained physician yield<br>information that may assist the<br>diagnosis. Contrast agents may<br>be used depending on the region<br>of interest of the scan. | Same |
| Magnet system | | | |
| Field Strength | 3.0 Tesla | 3.0 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessible<br>bore dimensions | 75cm | 75cm | Same |
| Type of 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 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 (K220332) | Remark |
| Resonant<br>frequencies | 128.23 MHz | 128.23 MHz | Same |
| Number of transmit<br>channels | 2 | 2 | Same |
| Number of receive<br>channels | Up to 96 | Up to 96 | Same |
| Amplifier peak<br>power per channel | 18 kW, 20 kW | 18 kW | Note 1 |
| RF Coils | | | |
| Volume Transmit<br>Coil | Yes | Yes | Same |
| Head & Neck Coil -<br>24 | Yes | Yes | Same |
| Body Array Coil -<br>12 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Flex Coil Large - 8 | Yes | Yes | Same |
| Flex Coil Small - 8 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower Extremity<br>Coil - 36 | Yes | Yes | Same |
| Shoulder Coil - 12 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Spine Coil - 32 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Cardiac Coil - 24 | Yes | Yes | Same |
| Temporomandibular<br>Joint Coil - 4 | Yes | Yes | Same |
| Foot & Ankle Coil -<br>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 |
| Head & Neck Coil -<br>48 | Yes | Yes | Same |
| Spine Coil - 48 | Yes | Yes | Same |
| Head Coil - 64 | Yes | Yes | Same |
| SuperFlex Body -<br>24 | Yes | Yes | Same |
| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR Omega (K220332) | Remark |
| SuperFlex Large -<br>12 | Yes | Yes | Same |
| SuperFlex Small -<br>12 | Yes | Yes | Same |
| Tx/Rx Knee Coil -<br>24 | Yes | No | Note 2 |
| SuperFlex Body<br>Wide - 24 | Yes | No | Note 3 |
| Dimensions | Patient Table:<br>width 640mm, height 880mm,<br>length 2620mm<br>Dockable Patient Table:<br>width 826mm, height 880mm,<br>length 2578mm | width 640mm, height 880mm,<br>length 2620mm…