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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 K212067
Device Name Deep Learning Image Reconstruction
Applicant
GE Healthcare Japan Corporation
7-127, 4-Chome, Asahigaoka,
Hino,  JP 191-8503
Applicant Contact Katelyn Rowley
Correspondent
GE Medical Systems, LLC
3000 North Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Katelyn Rowley
Regulation Number892.1750
Classification Product Code
JAK  
Date Received07/02/2021
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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