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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K103365
Device Name DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A
Applicant
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
1515 DANNER DR
AURORA,  OH  44202 -9273
Applicant Contact MICHAEL S PRETO
Correspondent
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
1515 DANNER DR
AURORA,  OH  44202 -9273
Correspondent Contact MICHAEL S PRETO
Regulation Number892.1000
Classification Product Code
MOS  
Date Received11/17/2010
Decision Date 01/12/2011
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
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