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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 K220961
Device Name Deep Learning Image Reconstruction
Applicant
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka
Hino,  JP 191-8503
Applicant Contact Wang Xing
Correspondent
GE Hangwei Medical Systems Co., Ltd.
West Area of Building No.3, No.1 Yongchang North Road
Beijing Economic & Technological Develop,  CN 100176
Correspondent Contact Wang Xing
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/01/2022
Decision Date 07/29/2022
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
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