510(k) K192924

MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit by Siemens Medical Solutions USA, Inc. — Product Code LNH

K192924 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit". The FDA issued a decision of Substantially Equivalent on Mar 11, 2020. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 11, 2020
Date Received
Oct 16, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Nuclear Magnetic Resonance Imaging
Device Class
Class II
Regulation Number
892.1000
Review Panel
RA
Submission Type
510(k)