uMR 570

K230758 · Shanghai United Imaging Healthcare Co., Ltd. · LNH · May 18, 2023 · Radiology

Device Facts

• Record ID: K230758
• Device Name: uMR 570
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: May 18, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The uMR 570 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

The uMR 570 is a 1.5T superconducting MRI system with a 70cm bore. It acquires MR signals via RF coils and gradient coils, processed by a spectrometer and computer system. The device generates sagittal, transverse, coronal, and oblique cross-sectional and spectroscopic images. Operated by trained clinicians in a clinical setting, the system provides anatomical and functional data to assist in diagnosis. New features include advanced pulse sequences (e.g., fse_dwi, asl_3d, gre_bssfp), automated processing methods (Inline T2, Cardiac T1/T2/T2* mapping, Flow Quantification, 3D ASL), and spectroscopy (Liver, Prostate, Breast). Workflow enhancements include EasyScan and Remote Assistance. The device supports vital signal gating (ECG, respiratory). Output is interpreted by physicians to inform clinical decision-making, potentially improving diagnostic accuracy through advanced imaging and quantification.

Clinical Evidence

Bench testing only. Performance evaluation reports were provided for new software features including Flow Quantification, 3D ASL, Inline T2 mapping, Cardiac T1/T2/T2* mapping, MARS+, MultiBand, QScan, Silicon-Only Imaging, and spectroscopy (Prostate, Breast, Liver). System validation was conducted for Implant mode, Remote Assistance, and EasyScan. Testing demonstrated the device performs as expected.

Technological Characteristics

1.5T superconducting magnet; 70cm bore; active shielding; 45mT/m max gradient amplitude; 200T/m/s max slew rate; 48 receive channels; 20kW RF amplifier. Complies with NEMA and DICOM standards. Biocompatibility per ISO 10993-5/10. Electrical safety per ES60601-1; EMC per IEC60601-1-2; SAR/dB/dt per IEC 60601-2-33. Surface heating per NEMA MS 14-2019.

Indications for Use

Indicated for use as an MRDD to produce cross-sectional 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 570 (K201540)

Reference Devices

• uMR 680 (K222755)

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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

May 18, 2023

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

Re: K230758

Trade/Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: March 20, 2023 Received: March 20, 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

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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 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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230758

Device Name uMR 570

Indications for Use (Describe)

The uMR 570 system is indicated for use as a magnetic resonance diagnostic 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) |
|-------------------------------------------------|
|-------------------------------------------------|

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/2 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is dark blue with a white line running vertically through the center. The logo is simple and modern, and the use of blue and white gives it a clean and professional look.

### 510 (k) SUMMARY

### 1. Date of Prepared

March 20, 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 570 Common Name: Magnetic Resonance Diagnostic Device Model: uMR 570 Product Code: LNH Regulation Number: 21 CFR 892.1000 Device Class: II

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

Predicate Device 510(k) Number: K201540 Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

Reference Device 510(k) Number: K222755 Device Name: uMR 680 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized letter "U" that is dark teal in color. The logo is simple and modern.

## 5. Device Description

The uMR 570 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm 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 570 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

The modification performed on the uMR 570 (K201540) in this submission is due to the following changes that include:

- (1) Addition and modification of pulse sequences
- a) New sequences: fse_dwi, grase, asl_3d, fse_mars_sle, gre_fine, gre_fg, gre bssfp ucs. svs wfs. svs stme.
- b) Added associated options for certain sequences: se_me (Add Inline T2 mapping), fse (Add OScan, Silicon-Only Image), fse arms (Add QScan), fse_mx (Add QScan), fse_ssh (Add QScan, Silicon-Only Image), fse_wfi (Add QScan), se (Add QScan), epi_dwi (Add QScan, MultiBand), epi_bold (Add QScan, MultiBand), epi_dti (Add QScan, MultiBand), gre_swi (Add QScan), gre_fsp (Add QScan), gre_quick (Add QScan), gre (Add QScan), gre_fsp_c (Add Cardiac T2* mapping), gre_bssfp (Add Cardiac T1 mapping, Cardiac T2 mapping).
- c) Added additional accessory equipment required for certain sequences: gre_tof (Add respiratory, cardiac gating).
- (2) Addition of MR imaging processing methods: Inline T2 mapping, Cardiac T1 mapping, Cardiac T2 mapping, Cardiac T2* mapping, Flow Quantification, Arterial Spin Labeling (3D ASL).
- (3) Addition of Spectroscopy Sequences and Post Processing Features: SVS MRS (Liver), Prostate MRS, SVS MRS (Breast).
- (4) Addition of New function: Implant mode, Remote Assistance.
- (5) Addition of New Workflow Features: EasyScan.

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

## 6. Intended Use

The uMR 570 system system are 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

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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" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which also resembles a shield with a vertical line through the center. The color of the logo is a dark teal or gray.

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

| ITEM | Proposed Device<br>uMR 570 | Predicate Device<br>uMR 570 (K201540) | Remark |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| General | | | |
| 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 570 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 570 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<br>region of interest of the scan. | Same |
| Magnet system | | | |
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessible<br>bore dimensions | width 700mm,<br>height 530mm,<br>length 1500mm | width 700mm,<br>height 530mm,<br>length 1500mm | Same |
| Type of Shielding | Actively shielded, OIS<br>technology | Actively shielded, OIS<br>technology | Same |
| Magnet<br>Homogeneity | 1.4ppm @ 50cm DSV<br>0.9ppm @ 45cm DSV<br>0.72ppm @ 40cm DSV<br>0.420ppm @ 30cm DSV<br>0.240ppm @ 20cm DSV<br>0.040ppm @ 10cm DSV | 1.4ppm @ 50cm DSV<br>0.9ppm @ 45cm DSV<br>0.72ppm @ 40cm DSV<br>0.420ppm @ 30cm DSV<br>0.240ppm @ 20cm DSV<br>0.040ppm @ 10cm DSV | Same |
| ITEM | Proposed Device<br>uMR 570 | Predicate Device<br>uMR 570 (K201540) | Remark |
| 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 | | | |
| Resonant<br>frequencies | 63.87 MHz | 63.87 MHz | Same |
| Number of transmit<br>channels | 1 | 1 | Same |
| Number of receive<br>channels | Up to 48 | Up to 48 | Same |
| Amplifier peak<br>power per channel | 20 kW | 20 kW | Same |
| RF Coils | | | |
| Head & Neck Coil -<br>16 | Yes | Yes | Same |
| Body Array Coil - 6 | Yes | Yes | Same |
| Body Array Coil -<br>12 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Flex Coil Large - 4 | Yes | Yes | Same |
| Flex Coil Small - 4 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower Extremity<br>Coil - 24 | Yes | Yes | Same |
| Shoulder Coil - 12 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Spine Coil - 24 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Cardiac Coil - 24 | Yes | Yes | Same |
| Foot & Ankle Coil<br>- 24 | Yes | Yes | Same |
| Temporomandibula<br>r Joint Coil - 4 | Yes | Yes | Same |
| Head Coil - 24 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Patient table | | | |
| Dimensions | width 640mm,<br>height 880mm,<br>length 2620mm | width 640mm,<br>height 880mm,<br>length 2620mm | Same |
| ITEM | Proposed Device<br>uMR 570 | Predicate Device<br>uMR 570 (K201540) | Remark |
| Maximum supported patient<br>weight | 250 kg | 250 kg | Same |
| Accessories | | | |
| Vital Signal Gating | ECG, Peripheral Pulse Gating,<br>Respiratory Gating | ECG, Peripheral Pulse Gating,<br>Respiratory Gating | Same |
| Safety | | | |
| Electrical Safety | Comply with ES60601-1 | Comply with ES60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Max SAR for<br>Transmit Coil | Comply with IEC 60601-2-33 | Comply with IEC 60601-2-33 | Same |
| Max dB/dt | Comply with IEC 60601-2-33 | Comply with IEC 60601-2-33 | Same |
| Biocompatibility | Patient Contact Materials were<br>tested and demonstrated no<br>cytotoxicity (ISO 10993-5), no<br>evidence for irritation and<br>sensitization (ISO 10993-10). | Patient Contact Materials were<br>tested and demonstrated no<br>cytotoxicity (ISO 10993-5), no<br>evidence for irritation and<br>sensitization (ISO 10993-10). | Same |
| Surface Heating | NEMA MS 14 | ES 60601-1 | Note 1 |

Table 1 Comparison of Hardware configuration

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