FlightPlan For Embolization

System, Image Processing, Radiological

GE Medical Systems SCS

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

Pre-market Notification Details

Device IDK193261
510k NumberK193261
Device Name:FlightPlan For Embolization
ClassificationSystem, Image Processing, Radiological
Applicant GE Medical Systems SCS 283, Rue De La Miniere Buc,  FR 78530
ContactNing Wen
CorrespondentNing Wen
GE Medical Systems SCS 283, Rue De La Miniere Buc,  FR 78530
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-01-24

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