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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 STREET
SUITE 4
WILMINGTON,  MA  01887
Applicant Contact YUAN MA
Correspondent
GE MEDICAL SYSTEMS, LLC
301 BALLARDVALE STREET
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
Recalls CDRH Recalls
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