The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Magnetom Lumina And Magnetom Vida Fit With Syngo Mr Xa50a.
| Device ID | K220939 |
| 510k Number | K220939 |
| Device Name: | MAGNETOM Lumina And MAGNETOM Vida Fit With Syngo MR XA50A |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Malvern, PA 19355 |
| Contact | Alina Goodman |
| Correspondent | Alina Goodman Siemens Medical Solutions USA Inc. 40 Liberty Blvd. Malvern, PA 19355 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-04-29 |