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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 K132376
Device Name DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
Applicant
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
3200 N. GRANDVIEW BLVD
WAUKESHA,  WI  53188
Applicant Contact MICHELLE HUETTNER
Correspondent
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
3200 N. GRANDVIEW BLVD
WAUKESHA,  WI  53188
Correspondent Contact MICHELLE HUETTNER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/30/2013
Decision Date 11/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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