Mimics InPrint

System, Image Processing, Radiological

Materialise NV

The following data is part of a premarket notification filed by Materialise Nv with the FDA for Mimics Inprint.

Pre-market Notification Details

Device IDK173619
510k NumberK173619
Device Name:Mimics InPrint
ClassificationSystem, Image Processing, Radiological
Applicant Materialise NV Technologielaan 15 Leuven,  BE 3001
ContactOliver Clemens
CorrespondentOliver Clemens
Materialise NV Technologielaan 15 Leuven,  BE 3001
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-22
Decision Date2018-03-21
Summary:summary

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