The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Aera (24-channel), Magnetom Avanto Fit, Magnetom Skyra Fit, Magnetom Prisma, Magnetom Prisma Fit.
| Device ID | K151579 |
| 510k Number | K151579 |
| Device Name: | MAGNETOM Aera (24-channel), MAGNETOM Avanto Fit, MAGNETOM Skyra Fit, MAGNETOM Prisma, MAGNETOM Prisma Fit |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY 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 | 2015-06-11 |
| Decision Date | 2015-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869015583 | K151579 | 000 |
| 04056869015149 | K151579 | 000 |
| 04056869014944 | K151579 | 000 |
| 04056869014937 | K151579 | 000 |
| 04056869014920 | K151579 | 000 |
| 04056869014906 | K151579 | 000 |
| 04056869014890 | K151579 | 000 |
| 04056869014883 | K151579 | 000 |
| 04056869014746 | K151579 | 000 |
| 04056869014739 | K151579 | 000 |
| 04056869014715 | K151579 | 000 |
| 04056869014708 | K151579 | 000 |
| 04056869014685 | K151579 | 000 |
| 04056869006659 | K151579 | 000 |
| 04056869015163 | K151579 | 000 |
| 04056869015170 | K151579 | 000 |
| 04056869015576 | K151579 | 000 |
| 04056869015484 | K151579 | 000 |
| 04056869015477 | K151579 | 000 |
| 04056869015460 | K151579 | 000 |
| 04056869015453 | K151579 | 000 |
| 04056869015415 | K151579 | 000 |
| 04056869015408 | K151579 | 000 |
| 04056869015392 | K151579 | 000 |
| 04056869015262 | K151579 | 000 |
| 04056869015231 | K151579 | 000 |
| 04056869015224 | K151579 | 000 |
| 04056869015217 | K151579 | 000 |
| 04056869015200 | K151579 | 000 |
| 04056869006642 | K151579 | 000 |