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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
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