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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 K103238
Device Name 1.5T OPTIMA MR430S
Applicant
GE MEDICAL SYSTEMS, LLC
301 BALLARDVALE STREET
SUITE 4
WILMINGTON,  MA  01887
Applicant Contact NORMA LEMAY
Correspondent
GE MEDICAL SYSTEMS, LLC
301 BALLARDVALE STREET
SUITE 4
WILMINGTON,  MA  01887
Correspondent Contact NORMA LEMAY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/02/2010
Decision Date 02/11/2011
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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