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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 K211312
Device Name Universal Viewer
GE Healthcare
500 W. Monroe Street
Chicago,  IL  60661 -3671
Applicant Contact John Braam
GE Healthcare
500 W. Monroe Street
Chicago,  IL  60661 -3671
Correspondent Contact John Braam
Regulation Number892.2050
Classification Product Code
Date Received04/30/2021
Decision Date 05/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls