510(k) K103327

DISCOVERY MR750W 3.0T by Ge Healthcare Japan Corporation — Product Code LNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
November 12, 2010
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