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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 K131977
Device Name CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
Applicant
GE HEALTHCARE
540 W. NORTHWEST HIGHWAY
BARRINGTON,  IL  60010
Applicant Contact NICOLE LANDREVILLE
Correspondent
GE HEALTHCARE
540 W. NORTHWEST HIGHWAY
BARRINGTON,  IL  60010
Correspondent Contact NICOLE LANDREVILLE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/28/2013
Decision Date 09/17/2013
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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