uMR 560

K180926 · Shanghai United Imaging Healthcare Co., Ltd. · LNH · Jun 6, 2018 · Radiology

Device Facts

• Record ID: K180926
• Device Name: uMR 560
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: Jun 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The uMR 560 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 560 is a 1.5T superconducting magnetic resonance diagnostic device (MRDD) with a 60cm patient bore. It utilizes a magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, and computer system to acquire MR signals. The device transforms these signals into sagittal, transverse, coronal, and oblique cross-sectional images, as well as spectroscopic images. Operated by trained clinicians in a clinical setting, the device assists in diagnosing internal anatomical structures and functions. Contrast agents may be administered based on the region of interest. Physicians interpret the resulting images and derived physical parameters to inform clinical decision-making. The system conforms to NEMA and DICOM standards for image display and data handling.

Clinical Evidence

No clinical trials were conducted. Evidence includes a volunteer study to determine safety limits for gradient-induced nerve stimulation and sample clinical images demonstrating diagnostic quality in accordance with FDA MR guidance.

Technological Characteristics

1.5T superconducting magnet; 60cm bore; RF power amplifier; gradient power amplifier; RF coils; spectrometer; computer system. Conforms to NEMA and DICOM standards. Safety testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 60825-1, ISO 10993-5/10, and NEMA MS 1-6, 8-9.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, and extremities to visualize internal anatomical structures and function.

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

• MAGNETOM AREA (K132951)

Submission Summary (Full Text)

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Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang Qm&ra VP No.2258 Chengbei Road., Jiading Industrial District Shanghai, 201807 CHINA

Re: K180926

Trade/Device Name: uMR 560 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 6, 2018 Received: April 9, 2018

Dear Shumei Wang:

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. 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.

June 6th, 2018

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jeff Bargar

for

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K180926

Device Name uMR 560

Indications for Use (Describe)

The uMR 560 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) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Summary

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### 510 (k) SUMMARY

### 1. Date Prepared [21 CFR 807.92(a)(1)] March 16, 2018

### 2. General Information [21 CFR 807.92(a)(1)]

| Manufacturer: | Shanghai United Imaging Healthcare Co., Ltd<br>2258 Chengbei Rd., Jiading District, Shanghai, 201807 |
|-----------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Shumei Wang |

QM&RA VP Tel: [phone]-6776 Fax: [phone] Email: [e-mail]

### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| Trade Name: | uMR 560 |
|--------------------|--------------------------------------|
| Common Name: | Magnetic Resonance Diagnostic Device |
| Model: | uMR 560 |
| Product Code: | LNH |
| Regulation Number: | 892.1000 |
| Device Class: | II |

### 4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[

The identification of predicates device within this submission is as follow:

Predicate Device Manufacturer: SIEMENS AG MAGNETOM AREA Device Name: Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K132951

### 5. Device Description [21 CFR 807.92(a)(4)]

The uMR 560 is a 1.5T superconducting magnetic resonance diagnostic device with a

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

60cm 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 560 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

### 6. Intended Use [21 CFR 807.92(a)(5)]

The uMR 560 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 [21 CFR 807.92(a)(6)]

The uMR 560 has the same major technological characteristics as the predicate device. The differences from the predicate device including patient bore size, high order shimming configuration, interventional usage, RFPA power and external triggering function are discussed in the comparison table in this submission. The same scientific technology theory, similar physical design, same coil applications and functionalities are applied to both the uMR 560 and predicate device. The technical characteristic differences do not affect the safety and effectiveness of the uMR 560 for intended use.

#### Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)] 8.

### Summary of Non-Clinical Tests:

The following testing was conducted on the uMR 560 Magnetic Resonance Diagnostic Device as the predicate device:

- ES60601-1:2005/(R)2012. Medical Electrical Equipment Part 1: General A Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2 Edition 3.0 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- A 60601-2-33 Ed. 3.1:2013, Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

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Image /page/6/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 font. The color of the logo is a dark teal.

- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical A Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic A Resonance Imaging Devices
- A MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- A MS 8-2008, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- A MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images

The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.

### Summary of Clinical Tests:

- A A volunteer study was used to determine the safety limits associated with gradient-induced nerve stimulation.
- A Sample clinical images were provided to support the ability of uMR 560 to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.

### 9. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we concludes that uMR 560 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.

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