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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 K123068
Device Name OPTIMA MR 430S
Applicant
Ge Medical Systems, LLC
301 Ballardvale St.
Suite 4
Wilmington,  MA  01887
Applicant Contact YUAN MA
Correspondent
Ge Medical Systems, LLC
301 Ballardvale St.
Suite 4
Wilmington,  MA  01887
Correspondent Contact YUAN MA
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/01/2012
Decision Date 11/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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