Xeleris V Processing And Review Systems

System, Image Processing, Radiological

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Xeleris V Processing And Review Systems.

Pre-market Notification Details

Device IDK201103
510k NumberK201103
Device Name:Xeleris V Processing And Review Systems
ClassificationSystem, Image Processing, Radiological
Applicant GE Healthcare 4 Hayozma Street Tirat Hacarmel,  IL 30200
ContactAlexandra Lifshits
CorrespondentAlexandra Lifshits
GE Healthcare 4 Hayozma Street Tirat Hacarmel,  IL 30200
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-24
Decision Date2020-09-25

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