Flex Large 4 MR Coil 3t
Catalogue number 08625761, listed by Siemens Healthcare Limited, Canada, under Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance. 3 manufacturers in China are registered for this product code.
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) | K121434 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08625761 | 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
6 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 | 101 units | |
| 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 | 56 units | |
| 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 | 59 units | |
| 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 | 78 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 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2015-03-09 | Class II | Nonconforming Material/Component | The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur. | 132 | 2016-08-17 |
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.