The following data is part of a premarket notification filed by Siemens Medical Solutions, Usa, Inc. with the FDA for Magnetom Vida.
Device ID | K183254 |
510k Number | K183254 |
Device Name: | Magnetom Vida |
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 | 2018-11-21 |
Decision Date | 2019-01-18 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MAGNETOM VIDA 79205326 5377429 Live/Registered |
Siemens Healthcare GmbH 2017-01-24 |