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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
Applicant
Ge Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka
Hino,  JP 191-8503
Applicant Contact Tomohiro Ito
Correspondent
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Helen Peng
Regulation Number892.1750
Classification Product Code
JAK  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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