Breast Array CPL. 047
Catalogue number 03146979, listed by Siemens Healthcare Limited, Canada, under System, Nuclear Magnetic Resonance Spectroscopic. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Tianjin (2), Beijing (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | Tianjin | Specification developer | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | Tianjin | Specification developer | 3 |
Record
| Listed by | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | LNI |
| Device type | System, Nuclear Magnetic Resonance Spectroscopic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1000 |
| 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 |
|---|---|---|
| 03146979 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| System, Nuclear Magnetic Resonance Spectroscopic | GE Healthcare (Tianjin) Company Limited | 6 |
| Ingenia | Philips Medical Systems Nederland B.V. | 3 |
| System, Nuclear Magnetic Resonance Spectroscopic | Usa Instruments, Inc. | 2 |
| Magnetom Cima.X | Siemens Healthcare Limited | 2 |
| Magnetom Altea | Siemens Healthineers AG | 2 |
| 1.5T 32-ch Head Coil MR Coil | Siemens Healthcare Limited | 1 |
| CP Flex Coil Large 63 047 | Siemens Healthcare Limited | 1 |
| Magnetom Sola | Siemens Healthineers AG | 1 |
| Hitachi | Hitachi, Ltd. | 1 |
| Achieva | Philips Medical Systems Nederland B.V. | 1 |
| 1.5T Loop 7 cm MR coil kit | Siemens Healthcare Limited | 1 |
| PA 36 MR coil set 3T 098 | Siemens Healthcare Limited | 1 |
Showing 12 of 85. All products under System, Nuclear Magnetic Resonance Spectroscopic
Recalls Naming This Product
3 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 | 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 | 2015-03-09 | 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.