The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Magnetom Vida With Compressed Sensing Grasp-vibe.
Device ID | K173617 |
510k Number | K173617 |
Device Name: | MAGNETOM Vida With Compressed Sensing GRASP-VIBE |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Mailcode 65-1A Malvern, PA 19533 |
Contact | Cordell L. Fields |
Correspondent | Cordell L. Fields Siemens Medical Solutions USA, Inc. 65 Valley Stream Parkway Mailcode 65-1A Malvern, PA 19533 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-22 |
Decision Date | 2018-03-30 |
Summary: | summary |