CORONIS 5MP MAMMO SL, MODEL MDMG 6121

System, Image Processing, Radiological

BARCOVIEW, MEDICAL IMAGING SYSTEMS

The following data is part of a premarket notification filed by Barcoview, Medical Imaging Systems with the FDA for Coronis 5mp Mammo Sl, Model Mdmg 6121.

Pre-market Notification Details

Device IDK081109
510k NumberK081109
Device Name:CORONIS 5MP MAMMO SL, MODEL MDMG 6121
ClassificationSystem, Image Processing, Radiological
Applicant BARCOVIEW, MEDICAL IMAGING SYSTEMS 35 PRESIDENT KENNEDYPARK Kortrijk,  BE B-8500
ContactNeil Phillips
CorrespondentJeff D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2008-04-18
Decision Date2008-05-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05415334001480 K081109 000

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