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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K113490
Device Name OPTIMA MR450W
Original Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha,  WI  53188
Original Contact robin martin
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/25/2011
Decision Date 01/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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