Icobrain-ctp

System, Image Processing, Radiological

Icometrix NV

The following data is part of a premarket notification filed by Icometrix Nv with the FDA for Icobrain-ctp.

Pre-market Notification Details

Device IDK192962
510k NumberK192962
Device Name:Icobrain-ctp
ClassificationSystem, Image Processing, Radiological
Applicant Icometrix NV Kolonel Begaultlaan 1b/12 Leuven,  BE 3012
ContactDirk Smeets
CorrespondentDirk Smeets
Icometrix NV Kolonel Begaultlaan 1b/12 Leuven,  BE 3012
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-22
Decision Date2020-02-28

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