uMR 570

K200024 · Shanghai United Imaging Healthcare Co., Ltd. · LNH · Apr 20, 2020 · Radiology

Device Facts

• Record ID: K200024
• Device Name: uMR 570
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: Apr 20, 2020
• 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

uMR 570 is a 1.5T superconducting MRI system with 70cm bore; inputs include RF signals captured via specialized coils (Head, Carotid, etc.) during patient scanning. System transforms signals into cross-sectional and spectroscopic images using pulse sequences and reconstruction methods (e.g., compressed sensing). Operated by trained clinicians in clinical settings; output viewed on workstation displays. Provides anatomical/functional data to assist physician diagnosis. New features include automated slice positioning (Easy Scan), quantitative mapping (T1/T2*), and advanced reconstruction (PSIR, cDWI, SWI+). Benefits include improved image quality, faster acceleration, and streamlined workflow via automated positioning.

Clinical Evidence

Bench testing only. Performance evaluated via SNR, image uniformity, spectroscopy, surface heating, and compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-33. Specific performance testing conducted for new software features: Inline T1/T2* Map, SWI+, cDWI, and Easy Scan. Biocompatibility verified per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

1.5T superconducting magnet; 70cm bore; 45mT/m max gradient amplitude; 200T/m/s max slew rate. 1 transmit channel, up to 48 receive channels. Connectivity via DICOM/NEMA standards. Biocompatible patient contact materials (ISO 10993). Software includes advanced reconstruction (compressed sensing) and automated positioning algorithms.

Indications for Use

Indicated for patients requiring MR imaging of the head, body, and extremities to visualize internal anatomical structures and/or function. No specific age or gender contraindications provided.

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 (K180925)

Submission Summary (Full Text)

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

Re: K200024

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: April 3, 2020 Received: April 7, 2020

Dear Xin Gao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

April 20, 2020

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

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

Enclosure

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## Indications for Use

510(k) Number (if known)

K200024

Device Name uMR 570

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 imerpreted 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> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/2 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 graphic element that resembles a shield or emblem. The emblem is divided vertically by a white line, and a horizontal white line crosses the vertical line near the top, creating a "T" shape within the shield.

### 510 (k) SUMMARY

### 1. Date of Prepared

April 03, 2020

### 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: 892.1000 Device Class: II

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

Predicate Device 510(k) Number: K180925 Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

#### 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

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standards.

uMR 570 has been previously cleared by FDA via K180925.

The modification performed on the uMR 570(K180925) in this submission is due to the following changes that include:

- Addition of Radio Frequency Coils: Head Coil-24, Head Coil-12, Carotid Coil-8 1.
- Addition and modification of pulse sequences 2.
- New sequences: gre quick wfi, hise, gre quick 4dcemra, gre ute, a) gre_maps
- b) Broadened application scope of Contrast characteristic for certain sequences: T1,T2, Pd, T2/T1
- Added certain sequences Associated options: dark blood, navigator, multic) echo , reduced-FOV, cDWI
- Added Reconstruction method for certain sequences: compressed sensing d)
- 3. Addition of imaging processing methods: FACT(Fat Analysis and Calculation Technique), PSIR (Phase Sensitive Inversion Recovery), cDWI (Computed DWI), Inline T1/T2* Map, SWI+ (Susceptibility Weighted Imaging Plus)

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

### 6. 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.

### 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 570 | Predicate Device<br>uMR 570 (K180925) | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| ITEM | Proposed Device<br>uMR 570 | Predicate Device<br>uMR 570 (K180925) | Remark |
| Indications For Use | The uMR 570 system is<br>indicated for use as a<br>magnetic resonance<br>diagnostic device<br>(MRDD) that produces<br>sagittal, transverse,<br>coronal, and oblique<br>cross sectional images,<br>and spectroscopic<br>images, and that display<br>internal anatomical<br>structure and/or function<br>of 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. | The uMR 570 system is<br>indicated for use as a<br>magnetic resonance<br>diagnostic device<br>(MRDD) that produces<br>sagittal, transverse,<br>coronal, and oblique<br>cross sectional images,<br>and spectroscopic<br>images, and that display<br>internal anatomical<br>structure and/or function<br>of the 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. | Same |
| Magnet system | | | |
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessible bore<br>dimensions | width 700mm,<br>height 530mm,<br>length 1500mm | width 700mm,<br>height 530mm,<br>length 1500mm | Same |
| Type of<br>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 uMR 570 | Predicate Device uMR 570 (K180925) | Remark |
| Max gradient 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 frequencies | 63.87 MHz | 63.87 MHz | Same |
| Number of transmit channels | 1 | 1 | Same |
| Number of receive channels | Up to 48 | Up to 48 | Same |
| Amplifier peak power per channel | 20 kW | 20 kW | Same |
| RF Coils | | | |
| Head & Neck Coil -16 | Yes | Yes | Same |
| Body Array Coil - 6 | Yes | Yes | Same |
| Body Array Coil - 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 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 - 24 | Yes | Yes | Same |
| Temporomandibular Joint Coil - 4 | Yes | Yes | Same |
| ITEM | Proposed Device<br>uMR 570 | Predicate Device<br>uMR 570 (K180925) | Remark |
| Head Coil - 24 | Yes | No | The intended use is<br>equivalent to<br>previously cleared<br>Head & Neck Coil -16<br>for head scan. More<br>coil elements in the<br>new coil allow better<br>image quality and<br>acceleration. |
| Head Coil - 12 | Yes | No | The intended use is<br>equivalent to<br>previously cleared<br>Head & Neck Coil -16<br>for head scan. More<br>coil elements in the<br>new coil allow better<br>image quality and<br>acceleration. |
| Carotid Coil - 8 | Yes | No | The intended use is<br>equivalent to<br>previously cleared<br>Flex Coil Small - 4 for<br>neck scan. More coil<br>elements in the new<br>coil allow better image<br>quality and<br>acceleration. |
| Patient table | | | |
| Dimensions | width 640mm, height<br>880mm, length 2620mm | width 640mm, height<br>880mm, length<br>2620mm | Same |
| Maximum<br>supported<br>patient weight | 250 kg | 250 kg | Same |
| Accessories | |…