510(k) K162102

MAGNETOM Avantofit, MAGNETOM Skyrafit by Siemens Medi Cal Solutions, Inc. — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2016
Date Received
July 29, 2016
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