Who is the manufacturer of uMR 680?

Shanghai United Imaging Intelligence Co., Ltd. filed the 510(k) submission for uMR 680 (K222755).

What is the FDA product code for uMR 680?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for uMR 680?

510(k) clearance (submission type: Traditional).

Does uMR 680 use AI or machine learning?

Yes. uMR 680 (K222755) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like uMR 680?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like uMR 680 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

uMR 680

K222755 · Shanghai United Imaging Intelligence Co., Ltd. · LNH · Feb 16, 2023 · Radiology

Device Facts

Record ID	K222755
Device Name	uMR 680
Applicant	Shanghai United Imaging Intelligence Co., Ltd.
Product Code	LNH · Radiology
Decision Date	Feb 16, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The uMR 680 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 680 is a 1.5T superconducting MRI system with a 70cm bore. It acquires RF signals via various coils, processed by a spectrometer and computer system to generate anatomical and spectroscopic images. It includes the 'DeepRecon' deep-learning algorithm for image denoising and super-resolution. Operated by trained clinicians in clinical settings, the device assists in diagnosis by providing high-quality images. It supports vital signal gating (ECG/respiratory/pulse) and includes features like EasyScan for automatic slice positioning and remote assistance. The output is interpreted by physicians to inform clinical decision-making. Benefits include improved image SNR, resolution, and workflow efficiency.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing (safety/performance standards) and clinical image evaluation. DeepRecon algorithm performance was validated on 68 US subjects (diverse demographics) comparing DeepRecon images to non-DeepRecon (NADR) images. Results showed improved SNR (186.87 vs 137.03) and resolution (15.57% increase), with uniformity, contrast, and structure measurements within 5% of NADR. Radiologist review confirmed diagnostic quality.

Technological Characteristics

1.5T superconducting magnet; 70cm bore; active shielding (OIS technology). Connectivity: DICOM/NEMA compliant. Software: DeepRecon (DL-based denoising/super-resolution). Coils: Phased array. Cooling: Water. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-5/10, IEC 62464-1, NEMA MS series.

Indications for Use

Indicated for use as an MRDD to produce cross-sectional and spectroscopic images of the head, body, and extremities for diagnostic purposes. Applicable to all patient populations (age/gender) requiring MRI, subject to standard MRI contraindications.

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)

Related Devices

K243397 — uMR 680 · Shanghai United Imaging Healthcare Co., Ltd. · Jul 16, 2025
K243547 — uMR Ultra · Shanghai United Imaging Healthcare Co., Ltd. · Jul 17, 2025
K230758 — uMR 570 · Shanghai United Imaging Healthcare Co., Ltd. · May 18, 2023
K250246 — uMR Jupiter · Shanghai United Imaging Healthcare Co., Ltd. · Aug 5, 2025
K210611 — MAGNETOM Free.Max · Siemens Medical Solutions USA, Inc. · Jul 1, 2021

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. February 16, 2023 Shanghai United Imaging Intelligence Co., Ltd. % Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA Re: K222755 Trade/Device Name: uMR 680 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 11, 2023 Received: January 17, 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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) K222755 Device Name uMR 680 #### Indications for Use (Describe) The uMR 680 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 interest of the scan. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | | | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | #### 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 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" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal. ### 510 (k) SUMMARY K222755 - 1. Date Prepared [21 CFR 807.92(a)(1)] February 15, 2023 ### 2. General Information [21 CFR 807.92(a)(1)] | Manufacturer: | Shanghai United Imaging Healthcare Co., Ltd | | | |---------------|-------------------------------------------------------|--|--| | | 2258 Chengbei Rd., Jiading District, Shanghai, 201807 | | | Xin GAO Contact Person: Regulatory Affairs Specialist Tel: +86 (21) 67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com ### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] | Trade Name: | uMR 680 | |--------------------|--------------------------------------| | Common Name: | Magnetic Resonance Diagnostic Device | | Model: | uMR 680 | | 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: Shanghai United Imaging Healthcare Co., Ltd Magnetic Resonance Diagnostic Device Device Name: Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K201540 ### 5. Device Description [21 CFR 807.92(a)(4)] The uMR 680 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, # Page 1 of 11 {4}------------------------------------------------ Image /page/4/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 symbol that resembles the letter "U" with a horizontal line through the middle. The color of the logo is a dark teal or gray. spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards. ## 6. Intended Use [21 CFR 807.92(a)(5)] The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional imag es, and spectroscopic images, and that display internal anatomical structure and/or fu nction of the head, body and extremities. These images and the physical parameters derived from the images when interpreted by a trained physician vield information that may assist the diagnosis. Contrast agen ts may be used depending on the region of interest of the scan. ### 7. Technological Characteristic [21 CFR 807.92(a)(6)] The differences from the predicate device are discussed in the comparison table in this submission as below. | ITEM | This submission uMR 680 | Predicate Device uMR 570 | 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 680 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. | 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. | Same | | Magnet system | | | | | Field Strength | 1.5 Tesla | 1.5 Tesla | Same | | ITEM | This submission uMR 680 | Predicate Device uMR 570 | Remark | | Type of Magnet | Superconducting | Superconducting | Same | | Patient- accessible bore dimensions | 70cm | 70cm | Same | | Type of Shielding | Actively shielded, OIS technology | Actively shielded, OIS technology | Same | | Magnet Homogeneity | 1.40ppm @ 50cm DSV 0.90ppm @ 45cm DSV 0.45ppm @ 40cm DSV 0.190ppm @ 30cm DSV 0.120ppm @ 20cm DSV 0.040ppm @ 10cm DSV | 1.40ppm @ 50cm DSV 0.90ppm @ 45cm DSV 0.72ppm @ 40cm DSV 0.420ppm @ 30cm DSV 0.240ppm @ 20cm DSV 0.040ppm @ 10cm DSV | Note 1 | | 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 | | Resonant frequencies | 63.87 MHz | 63.87 MHz | Same | | Number of transmit channels | 1 | 1 | Same | | Number of receive channels | Up to 96 | Up to 48 | Note 2 | | Amplifier peak power per channel | 18 kW | 20 kW | Note 3 | | Head & Neck Coil -16 | No | Yes | Note 4 | | Head & Neck Coil -24 | Yes | No | Note 5 | | Spine Coil - 24 | No | Yes | Note 6 | | Spine Coil - 32 | Yes | No | Note 7 | | Body Array Coil - 6 | No | Yes | Note 8 | | Body Array Coil - 12 | Yes | Yes | Same | | Body Array Coil - 24 | Yes | No | Note 8 | | ITEM | This submission uMR 680 | Predicate Device uMR 570 | Remark | | Breast Coil - 10 | 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 | | Wrist Coil - 12 | Yes | Yes | Same | | Cardiac Coil - 24 | Yes | Yes | Same | | Foot & Ankle Coil - 24 | Yes | Yes | Same | | Temporoman dibular Joint Coil - 4 | Yes | Yes | Same | | Head Coil - 24 | No | Yes | Note 9 | | Head Coil - 12 | No | Yes | Note 9 | | Carotid Coil - 8 | Yes | Yes | Same | | Flex Coil Large - 4 | No | Yes | Note 10 | | Flex Coil Large - 8 | Yes | No | Note 10 | | Flex Coil Small - 4 | No | Yes | Note 11 | | Flex Coil Small - 8 | Yes | No | Note 11 | | Infant Coil-24 | Yes | No | Note 12 | | SuperFlex Large - 12 | Yes | No | Note 13 | | SuperFlex Small - 12 | Yes | No | Note 14 | | SuperFlex Body - 24 | Yes | No | Note 15 | | Patient table | Patient Table: 250 kg Dockable Patient Table: 310kg | | Patient Table: 250 kg No | | Maximum supported patient weight | | | Same Note 16 | | ITEM | This submission uMR 680 | Predicate Device uMR 570 | Remark | | Vital Signal Gating | Support ECG/Respiratory/Pulse signal triggering the scan | Support ECG/Respiratory/Pulse signal triggering the scan | Same | Table 1 Comparison of Hardware configuration {5}------------------------------------------------ Image /page/5/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 text is a stylized "U" shape, formed by two vertical lines connected by a horizontal line at the top, with a curved bottom. {6}------------------------------------------------ Image /page/6/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, with a white line running vertically and horizontally through the center of the "U". {7}------------------------------------------------ Image /page/7/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, which is formed by two vertical lines connected by a horizontal line in the middle. The logo is simple and modern in design. | Note 1 | The homogeneity of the magnet is equal or better at typical DSVs thus the clinical scanning of the proposed device is not limited compared to the predicate device. | |---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…