Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K133226
BIOGRAPH MMR · Siemens Medical Solutions USA, Inc. · decided 2013-11-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| mMR Head/Neck Matrix coil | 10606489 | Siemens Healthcare GmbH | OUO | 04056869015118 |
| Biograph mMR | 10433372 | Siemens Healthcare GmbH | KPS LNH LNI OUO | 04056869006741 |
| Flex Large 4 MR coil 3T | 08625761 | Siemens Healthcare GmbH | LNH LNI MOS OUO | 04056869014388 |
| Flex small 4 MR coil set 3T | 08626876 | Siemens Healthcare GmbH | LNH OUO | 04056869014524 |
| mMR Spine Matrix coil set | 10185549 | Siemens Healthcare GmbH | OUO | 04056869014777 |
| mMR Head | 10835409 | Siemens Healthcare GmbH | OUO | 04056869015446 |
| mMR Body coil set | 10606589 | Siemens Healthcare GmbH | OUO | 04056869015156 |
| mMR Head set | 10185548 | Siemens Healthcare GmbH | OUO | 04056869014760 |
| mMR Head/Neck coil set | 10185547 | Siemens Healthcare GmbH | OUO | 04056869014753 |
| mMR Spine coil | 10606491 | Siemens Healthcare GmbH | OUO | 04056869015125 |
| 3T Loop 4 cm MR coil kit | 08626850 | Siemens Healthcare GmbH | LNH LNI MOS OUO | 04056869014500 |
| Flex Small 4 MR coil 3T | 08625779 | Siemens Healthcare GmbH | LNH LNI MOS OUO | 04056869014395 |
| mMR Body coil | 10606492 | Siemens Healthcare GmbH | OUO | 04056869015132 |