The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Amira, Magnetom Sempra.
| Device ID | K183221 |
| 510k Number | K183221 |
| Device Name: | MAGNETOM Amira, MAGNETOM Sempra |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd, Mail Code 65-1A Malvern, PA 19355 |
| Contact | Martin Rajchel |
| Correspondent | Martin Rajchel Siemens Medical Solutions USA, Inc. 40 Liberty Blvd, Mail Code 65-1A Malvern, PA 19355 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869231211 | K183221 | 000 |
| 04056869148649 | K183221 | 000 |
| 04056869148656 | K183221 | 000 |
| 04056869148663 | K183221 | 000 |
| 04056869163383 | K183221 | 000 |
| 04056869165325 | K183221 | 000 |
| 04056869231105 | K183221 | 000 |
| 04056869231112 | K183221 | 000 |
| 04056869231129 | K183221 | 000 |
| 04056869231136 | K183221 | 000 |
| 04056869231167 | K183221 | 000 |
| 04056869231174 | K183221 | 000 |
| 04056869231204 | K183221 | 000 |
| 04056869148632 | K183221 | 000 |