510(k) K103327

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

K103327 is an FDA 510(k) premarket notification submitted by Ge Healthcare Japan Corporation for the device "DISCOVERY MR750W 3.0T". The FDA issued a decision of Substantially Equivalent on September 30, 2011. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare Japan Corporation has at least 9 other 510(k) clearances on record.

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