Deep Learning Image Reconstruction

System, X-ray, Tomography, Computed

GE Medical Systems, LLC.

The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Deep Learning Image Reconstruction.

Pre-market Notification Details

Device IDK183202
510k NumberK183202
Device Name:Deep Learning Image Reconstruction
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Medical Systems, LLC. 3000 N. Grandview Blvd. Waukesha,  WI  53188
ContactLee Bush
CorrespondentLee Bush
GE Medical Systems, LLC. 3000 N. Grandview Blvd. Waukesha,  WI  53188
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2019-04-12

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