Hepatic VCAR

System, X-ray, Tomography, Computed

GE Medical Systems SCS

The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Hepatic Vcar.

Pre-market Notification Details

Device IDK193281
510k NumberK193281
Device Name:Hepatic VCAR
ClassificationSystem, X-ray, Tomography, Computed
Applicant GE Medical Systems SCS 283 Rue De La Miniere Buc,  FR 78530
ContactLifeng Wang
CorrespondentLifeng Wang
GE Medical Systems SCS 283 Rue De La Miniere Buc,  FR 78530
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-27
Decision Date2020-03-20

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