3MATIC

System, Image Processing, Radiological

MATERIALISE N.V.

The following data is part of a premarket notification filed by Materialise N.v. with the FDA for 3matic.

Pre-market Notification Details

Device IDK060950
510k NumberK060950
Device Name:3MATIC
ClassificationSystem, Image Processing, Radiological
Applicant MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven,  BE 3001
ContactCarl Van Lierde
CorrespondentCarl Van Lierde
MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven,  BE 3001
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-06
Decision Date2006-05-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E3143MATICMEDICAL0 K060950 000
E31433MATICMEDICAL0 K060950 000

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