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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K112570
Device Name CENTRICITY CARDIO IMAGING
Applicant
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 W. NW HIGHWAY
BARRINGTON,  IL  60010
Applicant Contact JOHN MANARIK
Correspondent
GE HEALTHCARE INTEGRATED IT SOLUTIONS
540 W. NW HIGHWAY
BARRINGTON,  IL  60010
Correspondent Contact JOHN MANARIK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/06/2011
Decision Date 11/30/2011
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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