CORONIS COLOR 2MP AND MDCC 2121

System, Image Processing, Radiological

BARCOVIEW

The following data is part of a premarket notification filed by Barcoview with the FDA for Coronis Color 2mp And Mdcc 2121.

Pre-market Notification Details

Device IDK061928
510k NumberK061928
Device Name:CORONIS COLOR 2MP AND MDCC 2121
ClassificationSystem, Image Processing, Radiological
Applicant BARCOVIEW 35 PRESIDENT KENNEDYPARK Kortrijk,  BE B-8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
BARCOVIEW 35 PRESIDENT KENNEDYPARK Kortrijk,  BE B-8500
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-07
Decision Date2006-09-05
Summary:summary

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