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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, tomography, computed
510(k) Number K191777
Device Name Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Applicant
GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha,  WI  53188
Applicant Contact Laura Turner
Correspondent
GE Medical Systems, LLC
3000 N. Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Laura Turner
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/02/2019
Decision Date 07/26/2019
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
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