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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 K203169
Device Name Revolution Ascend
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka,
hino,  JP 191-8503
Applicant Contact tomohiro ito
GE Medical Systems, LLC
3000 North Grandview Blvd
waukesha,  WI  53188
Correspondent Contact helen peng
Regulation Number892.1750
Classification Product Code
Date Received10/23/2020
Decision Date 11/20/2020
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