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 IDK220961
510k NumberK220961
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
ContactWang Xing
CorrespondentWang Xing
GE Hangwei Medical Systems Co., Ltd. West Area Of Building No.3, No.1 Yongchang North Road Beijing Economic & Technological Develop,  CN 100176
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-01
Decision Date2022-07-29

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