The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Vida With Syngo Mr Xa50a.
Device ID | K213693 |
510k Number | K213693 |
Device Name: | MAGNETOM Vida With Syngo MR XA50A |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 |
Contact | Karthik Pillai |
Correspondent | Karthik Pillai Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 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 | 2021-11-23 |
Decision Date | 2022-02-25 |