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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
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka
Hino,  JP 191-8503
Applicant Contact Wang Xing
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
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