The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Aera, Magnetom Skyra/skyrafit, Magnetom Prisma/prismafit, Magnetom Avantofit.
| Device ID | K173592 |
| 510k Number | K173592 |
| Device Name: | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mailcode 65-1A Malvern, PA 19355 |
| Contact | Cordell L. Fields |
| Correspondent | Cordell L. Fields Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mailcode 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 | 2017-11-21 |
| Decision Date | 2018-02-13 |
| Summary: | summary |