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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 K193170
Device Name Deep Learning Image Reconstruction
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka,
Hino,  JP 191-8503
Applicant Contact Tomohiro Ito
GE Medical Systems, LLC
3000 North Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Helen Peng
Regulation Number892.1750
Classification Product Code
Date Received11/15/2019
Decision Date 12/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No