uPMR 790

K222540 · Shanghai United Imaging Healthcare Co., Ltd. · OUO · Nov 14, 2022 · Radiology

Device Facts

• Record ID: K222540
• Device Name: uPMR 790
• Applicant: Shanghai United Imaging Healthcare Co., Ltd.
• Product Code: OUO · Radiology
• Decision Date: Nov 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce 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. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Story

uPMR 790 is a combined 3.0T MRI and PET scanner; provides simultaneous, iso-centric acquisition of high-resolution metabolic (PET) and anatomic (MR) images. PET detectors integrated into MR bore. System includes superconducting magnet, RF coils, gradient coils, patient table, and software for scan control, image reconstruction, and management. Used in clinical settings by trained professionals. MR provides radiation-free attenuation correction maps for PET. New features include advanced pulse sequences (e.g., ASL, HISE), cardiac mapping, and AI-based PET attenuation correction (MRAC). Output consists of fused PET/MR images and spectroscopic data. Healthcare providers use these images to assess metabolic/physiological function and anatomical structure. Benefits include precise anatomical reference for PET studies and improved diagnostic information through simultaneous modality acquisition.

Clinical Evidence

No clinical trials were conducted. Evidence consists of non-clinical bench testing and performance evaluations. Performance of new features (ASL, cardiac mapping, spectroscopy, EasyScan/Plan) and PET/MR image quality was verified. AI-based MRAC performance was validated using a test cohort (n=27) independent of the training set (n=130); results showed average SUVmean error in major brain regions <3%, meeting the <10% acceptance criterion.

Technological Characteristics

3.0T superconducting magnet; 60cm bore; 45mT/m max gradient amplitude; 200T/m/s max slew rate; 48 receive channels. Conforms to NEMA MS 14-2019, NEMA NU 2, IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-33. Biocompatibility per ISO 10993-5 and 10993-10. Software includes AI-based CNN for PET attenuation correction. Connectivity via DICOM standards.

Indications for Use

Indicated for patients requiring diagnostic imaging of the head, body, and extremities using simultaneous or independent MR and PET modalities to assess metabolic and physiological functions and internal anatomical structures.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• uPMR 790 (K192672)

Submission Summary (Full Text)

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November 14, 2022

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

Re: K222540

Trade/Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO Dated: October 21, 2022 Received: October 21, 2022

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Signature

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

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# Indications for Use

510(k) Number (if known) K222540

Device Name uPMR 790

#### Indications for Use (Describe)

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Position Tomography (PET) scanners that provide registration of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities. Contrast agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "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 bold text and a strong color palette makes it easily recognizable.

# 510 (k) SUMMARY

- 1. Date of Prepared
October 21, 2022

K222540

# 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: uPMR 790 Common Name: Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance Model: uPMR 790 Product Code: OUO Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system

Device Class: II

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

Predicate Device 510(k) Number: K192672 Device Name: uPMR 790 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO

### 5. Device Description

The uPMR 790 system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. It consists of components such as PET detector, 3.0T superconducting magnet, RF power

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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" shape, which is also in a bold, sans-serif font. The color of the logo is a dark gray.

amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, vital signal module, and software etc. The uPMR 790 system provides simultaneous acquisition of high resolution metabolic and anatomic information from PET and MR. PET detectors are integrated into the MR bore for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The system software is used for patient management, data management, scan control, image reconstruction, and image archive. The uPMR 790 system is designed to conform to NEMA and DICOM standards.

This traditional 510(k) is to request modifications for the cleared Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance.

The modifications performed on the uPMR 790 (K192672) in this submission are due to the following changes that include:

- (1)Addition and modification of pulse sequences:
- a) New sequences: hise, asl_3d, gre_quick_4dcemra, gre_maps.
- b) Added Associated options for certain sequences: navigator, T2* mapping, cardiac tagging, Perfusion, PSIR, Cine, cardiac T1 mapping, cardiac T2 mapping, cardiac T2* mapping, dark blood, SWI+ (multi-echo), cDWI, MicroView.
- (2) Addition of MR imaging processing methods: Phase Sensitive Inversion Recovery (PSIR), Computed DWI (cDWI), Inline T1/T2* Map, Susceptibility Weighted Imaging Plus (SWI+). Arterial Spin Labeling (ASL). Cardiac T1 Mapping. Cardiac T2 Mapping, Cardiac T2* Mapping.
- (3)Addition and modification of PET imaging processing methods:
- a) The new PET imaging processing method: Hyper Iterative.
- b) Modified MRAC method:WFI based head MRAC.
- (4)Addition VSM models: uVWMERP and uMVRX.
- (5) Addition Spectroscopy: HISE for Head Spectroscopy; Prostate Spectroscopy.

The modifications, which do not affect the intended use or alter the fundamental scientific technology of the device.

# 6. Indications for Use

The uPMR 790 system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and iso-centrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. The MR is intended to produce 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. Contrast

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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" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal.

agents may be used depending on the region of interest of the scan. The PET provides distribution information of PET radiopharmaceuticals within the human body to assist healthcare providers in assessing the metabolic and physiological functions. The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

# 7. Technological Characteristic

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

| ITEM | This Submission<br>uPMR 790 | Predicate Device<br>uPMR 790(K192672) | Remark | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(K) No. | K192672 | | | | |
| Product Code | OUO | OUO | Same | | |
| Regulation No. | 21 CFR 892.1200 | 21 CFR 892.1200 | Same | | |
| Class | II | II | Same | | |
| Indications For<br>Use | The uPMR 790 system<br>combines magnetic<br>resonance diagnostic<br>devices (MRDD) and<br>Positron Emission<br>Tomography (PET)<br>scanners that provide<br>registration and fusion of<br>high resolution<br>physiologic and anatomic<br>information, acquired<br>simultaneously and iso-<br>centrically. The combined<br>system maintains<br>independent functionality<br>of the MR and PET<br>devices, allowing for<br>single modality MR<br>and/or PET imaging. The<br>MR is intended to produce<br>sagittal, transverse,<br>coronal, and oblique cross<br>sectional images, and<br>spectroscopic images, and<br>that display internal<br>anatomical structure | The uPMR 790 system<br>combines magnetic<br>resonance diagnostic<br>devices (MRDD) and<br>Positron Emission<br>Tomography (PET)<br>scanners that provide<br>registration and fusion of<br>high resolution<br>physiologic and anatomic<br>information, acquired<br>simultaneously and iso-<br>centrically. The combined<br>system maintains<br>independent functionality<br>of the MR and PET<br>devices, allowing for<br>single modality MR<br>and/or PET imaging. The<br>MR is intended to produce<br>sagittal, transverse,<br>coronal, and oblique cross<br>sectional images, and<br>spectroscopic images, and<br>that display internal<br>anatomical structure | Same | | |
| | and/or function of the | and/or function of the | | | |
| | head, body and<br>extremities. Contrast | head, body and<br>extremities. Contrast | | | |
| | agents may be used | agents may be used | | | |
| | depending on the region | depending on the region | | | |
| | of interest of the scan. The | of interest of the scan. The | | | |
| | PET provides distribution | PET provides distribution | | | |
| | information of PET | information of PET | | | |
| | radiopharmaceuticals | radiopharmaceuticals | | | |
| | within the human body to | within the human body to | | | |
| | assist healthcare providers | assist healthcare providers | | | |
| | in assessing the metabolic | in assessing the metabolic | | | |
| | and physiological | and physiological | | | |
| | functions. The combined | functions. The combined | | | |
| | system utilizes the MR for | system utilizes the MR for | | | |
| | radiation-free attenuation | radiation-free attenuation | | | |
| | correction maps for PET | correction maps for PET | | | |
| | studies. The system | studies. The system | | | |
| | provides inherent | provides inherent | | | |
| | anatomical reference for | anatomical reference for | | | |
| | the fused PET and MR | the fused PET and MR | | | |
| | images due to precisely | images due to precisely | | | |
| | aligned MR and PET | aligned MR and PET | | | |
| | image coordinate systems. | image coordinate systems. | | | |
| Field Strength | 3.0 Tesla | 3.0 Tesla | Same | | |
| Type of Magnet | Superconducting | Superconducting | Same | | |
| Patient-accessible<br>bore dimensions | 60cm | 60cm | Same | | |
| Type of Shielding | Actively shielded, OIS<br>technology | Actively shielded, OIS<br>technology | Same | | |
| Magnet<br>Homogeneity | 2.400ppm @ 50cm DSV<br>0.800ppm @ 45cm DSV<br>0.390ppm @ 40cm DSV<br>0.110ppm @ 30cm DSV<br>0.038ppm @ 20cm DSV<br>0.020ppm @ 10cm DSV | 2.400ppm @ 50cm DSV<br>0.800ppm @ 45cm DSV<br>0.390ppm @ 40cm DSV<br>0.110ppm @ 30cm DSV<br>0.038ppm @ 20cm DSV<br>0.020ppm @ 10cm DSV | Same | | |
| 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 | | |
| Resonant<br>frequencies | 128.23MHz | 128.23MHz | Same | | |
| Number of<br>transmit channels | 2 | 2 | Same | | |
| Number of receive channels | 48…