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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
Applicant
GE Healthcare
500 West Monroe Street
chicago,  IL  60661 -3671
Applicant Contact renee webb
Correspondent
GE Healthcare
500 West Monroe Street
chicago,  IL  60661 -3671
Correspondent Contact renee webb
Regulation Number892.2050
Classification Product Code
LLZ  
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
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