FLIGHTPLAN FOR LIVER

System, Image Processing, Radiological

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Flightplan For Liver.

Pre-market Notification Details

Device IDK121200
510k NumberK121200
Device Name:FLIGHTPLAN FOR LIVER
ClassificationSystem, Image Processing, Radiological
Applicant GE HEALTHCARE 9900 W INNOVATION DR Wauwatosa,  WI  53226 -4856
ContactCarol Alloian
CorrespondentCarol Alloian
GE HEALTHCARE 9900 W INNOVATION DR Wauwatosa,  WI  53226 -4856
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-19
Decision Date2012-11-02
Summary:summary

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