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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 K213938
Device Name Revolution Ascend
Applicant
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka,
Hino,  JP 191-8503
Applicant Contact He Haibo
Correspondent
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka,
Hino,  JP 191-8503
Correspondent Contact He Haibo
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/16/2021
Decision Date 02/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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