Biograph mMR
MRI-PET Scanner
3manufacturers in China registered for this device type
1catalogue number
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 | Siemens Healthcare Limited, Canada |
|---|---|
| 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 | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K133226 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10433372 | 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 |
| uPMR | Shanghai United Imaging Healthcare Co., Ltd. | 1 |
Showing 12 of 22. All products under Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2025-08-28 | Class I | Under Investigation by firm | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the | 27 units | |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2015-12-07 | Class II | Other | Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blow | in US 3752 units | 2017-06-21 |
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.