510(k) K203443

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

K203443 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea". The FDA issued a decision of Substantially Equivalent on Mar 31, 2021. 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 31, 2021
Date Received
Nov 23, 2020
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)