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 IDK193170
510k NumberK193170
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
ContactTomohiro Ito
CorrespondentHelen Peng
GE Medical Systems, LLC 3000 North Grandview Blvd Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-15
Decision Date2019-12-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840682146586 K193170 000
00195278303202 K193170 000

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