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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
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