uMR Omega

K193200 · Shanghai United Imaging Healthcare Co., Ltd. · LNH · Mar 27, 2020 · Radiology

Device Facts

• Record ID: K193200
• Device Name: uMR Omega
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: Mar 27, 2020
• 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 featuring an ultra-wide 75cm patient bore. It acquires MR signals via RF coils and gradient systems, processing them into sagittal, transverse, coronal, and oblique cross-sectional or spectroscopic images. Operated by trained clinicians in a hospital or imaging center, the system supports patient weights up to 310kg. Output images and derived physical parameters are interpreted by physicians to assist in clinical diagnosis. The device includes automated features like 'Easy Scan' for slice positioning and advanced reconstruction techniques (PSIR, cDWI, SWI+). It integrates with vital signal gating (ECG, pulse, respiratory) to manage motion artifacts. The larger bore and increased receive channels (up to 96) enhance patient comfort and imaging coverage compared to previous models, facilitating diagnostic assessment of anatomical structures and function.

Clinical Evidence

Clinical evidence includes a volunteer study to determine safety limits for gradient-induced nerve stimulation and sample clinical images demonstrating diagnostic quality. No formal clinical trials with primary endpoints were required; substantial equivalence is supported by bench testing and compliance with NEMA/IEC standards.

Technological Characteristics

3.0T superconducting magnet; 75cm bore; 45mT/m max gradient amplitude; 200T/m/s max slew rate; 96 receive channels; 18kW RF amplifier power. Complies with ES60601-1, IEC 60601-1-2, IEC 60601-2-33, and ISO 10993 (biocompatibility). Connectivity via DICOM. Software features include non-uniformity/distortion correction, WFI, SWI, PC, GETI, ADC, PSIR, cDWI, SWI+, and Easy Scan (automated slice positioning).

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, and extremities to visualize internal anatomical structures and function. No specific age or gender restrictions; 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 780 (K191157)

Submission Summary (Full Text)

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

Re: K193200

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: March 11, 2020 Received: March 12, 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

March 27, 2020

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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,

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) K193200

Device Name uMR Omega

Indications for Use (Describe)

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 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 the scan.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> <svg class="bi bi-check-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> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> </span> </div> |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <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> </div> |

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Image /page/3/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 is dark gray. The logo is simple and modern.

# 510 (k) SUMMARY

K193200

# 1. Date of Prepared

March 11, 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 Omega Common Name: Magnetic Resonance Diagnostic Device Model(s): uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH

# 4. Identification of Predicate Device(s)

Predicate Device 510(k) Number: K191157 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 ultra-wide patient bore size design. 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

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Image /page/4/Picture/1 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 "U" symbol, which is also in a bold font. The color of the text and the "U" symbol appears to be a dark gray or charcoal color.

Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.

# 6. Indications for 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 is added below.

| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR 780 (K191157) | 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<br>system is indicated<br>for use as a magnetic<br>resonance<br>diagnostic<br>device<br>(MRDD)<br>that<br>produces<br>sagittal,<br>transverse, coronal,<br>and oblique cross<br>sectional images,<br>and spectroscopic<br>images , and that<br>display internal<br>anatomical structure<br>and/or function of<br>the head, body and<br>extremities.<br>These images and<br>the physical<br>parameters derived | The uMR 780<br>system is indicated<br>for use as a magnetic<br>resonance<br>diagnostic device<br>(MRDD) that<br>produces sagittal,<br>transverse, coronal,<br>and oblique cross<br>sectional images,<br>and spectroscopic<br>images, and that<br>display internal<br>anatomical structure<br>and/or function of<br>the head, body and<br>extremities.<br>These images and<br>the physical<br>parameters derived | Same |
| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR 780 (K191157) | Remark |
| | from the images | from the images | |
| | when interpreted by<br>a trained physician | when interpreted by<br>a trained physician | |
| | yield information<br>that may assist the<br>diagnosis. Contrast<br>agents may be used<br>depending on the<br>region of interest of<br>the scan. | yield information<br>that may assist the<br>diagnosis. Contrast<br>agents may be used<br>depending on the<br>region of interest of<br>the 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 | 65cm | Larger bore size for patients<br>comfort during scanning<br>without compromising other<br>imaging functions. |
| Type of<br>Shielding | Actively shielded,<br>OIS technology | Actively shielded,<br>OIS technology | Same |
| Magnet<br>Homogeneity | 2.3ppm @ 50cm DSV<br>0.8ppm @ 45cm DSV<br>0.38ppm @ 40cm<br>DSV<br>0.08ppm @ 30cm<br>DSV<br>0.02ppm @ 20cm<br>DSV<br>0.002ppm @ 10cm<br>DSV | 2.4ppm @ 50cm DSV<br>0.8ppm @ 45cm DSV<br>0.39ppm @ 40cm<br>DSV<br>0.11ppm @ 30cm<br>DSV<br>0.038ppm @ 20cm<br>DSV<br>0.002ppm @ 10cm<br>DSV | In order to support larger bore<br>size, uMR Omega system has a<br>bigger magnet design.<br>Compared with the predicate<br>device, the size and 5-gauss<br>line range is larger. The<br>homogeneity of the magnet is<br>equal or better at typical DSVs<br>thus clinical scanning is not<br>limited compared to predicate<br>device. |
| Gradient system | | | |
| Max gradient<br>amplitude | 45mT/m | 42mT/m | The higher Maximum Gradient<br>Strength allows uMR Omega<br>to achieve the shorter TE time<br>than predicate device in certain<br>imaging sequence. The system<br>effectiveness and safety were<br>verified by the third party<br>report. |
| Max slew rate | 200T/m/s | 200T/m/s | Same |
| Shielding | active | active | Same |
| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR 780 (K191157) | Remark |
| RF system | | | |
| 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 48 | More receive channels allow<br>uMR Omega to use new high-<br>channel count and bigger<br>coverage receive coils. |
| Amplifier peak<br>power per<br>channel | 18 kW | 18 kW | Same |
| RF Coils | | | |
| Head & Neck<br>Coil - 24 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Head Coil - 32 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Temporomandibular Joint Coil -<br>4 | Yes | Yes | Same |
| Infant Coil - 24 | Yes | Yes | Same |
| Spine Coil - 32 | Yes | Yes | Same |
| Body Array Coil<br>- 12 | Yes | Yes | Same |
| Cardiac Coil -<br>24 | Yes | Yes | Same |
| Flex Coil Large<br>- 8 | Yes | Yes | Same |
| Flex Coil Small<br>- 8 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Shoulder Coil -<br>12 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower Extremity<br>Coil - 36 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Foot & Ankle<br>Coil - 24 | Yes | Yes | Same |
| ITEM | Proposed Device<br>uMR Omega | Predicate Device<br>uMR 780 (K191157) | Remark |
| Body Array Coil<br>- 24 | Yes | No | The intended use is equivalent<br>to previously cleared Body<br>Array Coil -12. More coil<br>elements in the new coil allow<br>larger coverage for bigger<br>patient. |
| Patient table | | | |
| Dimensions | width 640mm,<br>height 880mm,<br>length 2620mm | width 640mm,<br>height 880mm,<br>length 2620mm | Same |
| Maximum<br>supported<br>patient weight | 310 kg | 250kg | Increased table supporting<br>weight allows bigger and<br>heavier patient to be scanned. |
| Accessories | | | |
| Vital Signal<br>Gating | ECG, Peripheral Pulse<br>Gating, Respiratory<br>Gating | ECG, Peripheral Pulse<br>Gating, Respiratory<br>Gating | Same |
| Safety | | | |
| Electrical Safety | Comply with<br>ES60601-1 | Comply with<br>ES60601-1 | Same |
| EMC | Comply with<br>IEC60601-1-2 | Comply with<br>IEC60601-1-2 | Same |
| Max SAR for<br>Transmit Coil | Comply with IEC<br>60601-2-33 | Comply with IEC<br>60601-2-33 | Same |
| Max dB/dt | Comply with IEC<br>60601-2-33…