uPMR
The uPMR 790 combines magnetic resonance and positron emission tomography. Its filing describes simultaneous acquisition of physiologic and anatomic information, while also allowing MR or…
The uPMR 790 combines magnetic resonance and positron emission tomography. Its filing describes simultaneous acquisition of physiologic and anatomic information, while also allowing MR or PET imaging as a single modality.
The MR component is intended to produce cross-sectional and spectroscopic images showing internal anatomy or function in the head, body and extremities.
Listed Item
Positron Emission Tomography and Magnetic Resonance Imaging System
Imaging Functions
The filing says PET provides radiopharmaceutical distribution information to assist healthcare providers in assessing metabolic and physiological functions. It also describes MR use for attenuation correction maps in PET studies.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
Record
| Listed by | Shanghai United Imaging Healthcare Co., Ltd., China |
|---|---|
| FDA product code | OUO |
| Device type | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1200 |
| Establishment | Manufacturer |
| 510(k) | K192672 |
| Record published | 2023-10-08 |
| Record revised | 2025-09-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| uPMR 790 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | GE Medical Systems, L.L.C. | 13 |
| Symphony™ | Qfix | 3 |
| Flex small 4 MR coil set 3T | Siemens Healthcare Limited | 2 |
| Lithotomy AirShuttle™ | Qfix | 1 |
| ZiFix™ | Qfix | 1 |
| mMR Head | Siemens Healthcare Limited | 1 |
| 3T Loop 4 cm MR coil kit | Siemens Healthcare Limited | 1 |
| mMR Head set | Siemens Healthcare Limited | 1 |
| mMR Head/Neck coil set | Siemens Healthcare Limited | 1 |
| mMR Head/Neck Matrix coil | Siemens Healthcare Limited | 1 |
| mMR Body coil set | Siemens Healthcare Limited | 1 |
| 3T Body Matrix MR coil set, Verio | Siemens Healthcare Limited | 1 |
Showing 12 of 22. All products under Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234154 | 2024-05-24 |
| K222540 | 2022-11-14 |
| K192672 | 2019-11-20 |
| K183014 | 2019-02-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.