Deep Learning Image Reconstruction

System, X-ray, Tomography, Computed

GE Healthcare Japan Corporation

The following data is part of a premarket notification filed by Ge Healthcare Japan Corporation with the FDA for Deep Learning Image Reconstruction.

Pre-market Notification Details

Device IDK212067
510k NumberK212067
Device Name:Deep Learning Image Reconstruction
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Healthcare Japan Corporation 7-127, 4-Chome, Asahigaoka, Hino,  JP 191-8503
ContactKatelyn Rowley
CorrespondentKatelyn Rowley
GE Medical Systems, LLC 3000 North Grandview Blvd Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-02
Decision Date2021-09-17

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