FlightPlan For Liver

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 Liver.

Pre-market Notification Details

Device IDK210807
510k NumberK210807
Device Name:FlightPlan For Liver
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-17
Decision Date2021-10-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.