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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 K182419
Device Name Centricity Universal Viewer
GE Healthcare
500 West Monroe Street
Chicago,  IL  60661 -3671
Applicant Contact Renee Webb
GE Healthcare
500 West Monroe Street
Chicago,  IL  60661 -3671
Correspondent Contact Renee Webb
Regulation Number892.2050
Classification Product Code
Date Received09/05/2018
Decision Date 12/14/2018
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