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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 K091536
Device Name OPTIMA MR450W
Original Applicant
GE MEDICAL SYSTEMS, LLC
3200 n. grandview blvd.
waukesha,  WI  53188
Original Contact mark stauffer
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/26/2009
Decision Date 07/17/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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