CORONIS FUSION 4MP DL

System, Image Processing, Radiological

BARCO NV

The following data is part of a premarket notification filed by Barco Nv with the FDA for Coronis Fusion 4mp Dl.

Pre-market Notification Details

Device IDK111989
510k NumberK111989
Device Name:CORONIS FUSION 4MP DL
ClassificationSystem, Image Processing, Radiological
Applicant BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
ContactLieven De Wandel
CorrespondentLieven De Wandel
BARCO NV 35 PRESIDENT KENNEDYPARK Kortrijk,  BE 8500
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-13
Decision Date2011-09-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415334001510 K111989 000

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