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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 St.
Suite 4
Wilmington,  MA  01887
Applicant Contact NORMA LEMAY
Correspondent
Ge Medical Systems, LLC
301 Ballardvale St.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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