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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 K150420
Device Name Centricity Universal Viewer
Applicant
GE HEALTHCARE
540 W NORTHWEST HIGHWAY
BARRINGTON,  IL  60010
Applicant Contact CHERYL BORK
Correspondent
GE HEALTHCARE
540 W NORTHWEST HIGHWAY
BARRINGTON,  IL  60010
Correspondent Contact CHERYL BORK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/18/2015
Decision Date 05/26/2015
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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