The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Vida, Magnetom Sola.
Device ID | K220425 |
510k Number | K220425 |
Device Name: | MAGNETOM Vida, MAGNETOM Sola |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 |
Contact | Alina Goodman |
Correspondent | Alina Goodman Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-14 |
Decision Date | 2022-03-11 |