SurgiCase Viewer

System, Image Processing, Radiological

Materialise NV

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

Pre-market Notification Details

Device IDK213684
510k NumberK213684
Device Name:SurgiCase Viewer
ClassificationSystem, Image Processing, Radiological
Applicant Materialise NV Technologielaan 15 Leuven,  BE 3001
ContactAya Nishikawa
CorrespondentAya Nishikawa
Materialise NV Technologielaan 15 Leuven,  BE 3001
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-22
Decision Date2022-06-15

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