The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Magnetom Vida, Magnetom Lumina, Magnetom Vida Fit.
| Device ID | K192924 |
| 510k Number | K192924 |
| Device Name: | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit |
| 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 | 2019-10-16 |
| Decision Date | 2020-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869245188 | K192924 | 000 |
| 04056869260143 | K192924 | 000 |
| 04056869260136 | K192924 | 000 |