The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Vida, Magnetom Sola, Magnetom Lumina, Magnetom Altea.
| Device ID | K203443 |
| 510k Number | K203443 |
| Device Name: | MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mailcode 65-1A Malvern, PA 19355 |
| Contact | Andrew Turner |
| Correspondent | Andrew Turner 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 | 2020-11-23 |
| Decision Date | 2021-03-31 |