MediCAD Web

System, Image Processing, Radiological

MediCAD Hectec GmbH

The following data is part of a premarket notification filed by Medicad Hectec Gmbh with the FDA for Medicad Web.

Pre-market Notification Details

Device IDK183412
510k NumberK183412
Device Name:MediCAD Web
ClassificationSystem, Image Processing, Radiological
Applicant mediCAD Hectec GmbH Opalstrasse 54 Altdorf,  DE 84032
ContactClaas-fabian Lueers
CorrespondentClaas-fabian Lueers
mediCAD Hectec GmbH Opalstrasse 54 Altdorf,  DE 84032
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-10
Decision Date2019-10-31

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