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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 K230807
Device Name Deep Learning Image Reconstruction
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 Received03/23/2023
Decision Date 04/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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