Segment 3DPrint

System, Image Processing, Radiological

Medviso AB

The following data is part of a premarket notification filed by Medviso Ab with the FDA for Segment 3dprint.

Pre-market Notification Details

Device IDK211966
510k NumberK211966
Device Name:Segment 3DPrint
ClassificationSystem, Image Processing, Radiological
Applicant Medviso AB Griffelvägen 3 Lund,  SE Se-22467
ContactEinar Heiberg
CorrespondentEinar Heiberg
Medviso AB Griffelvägen 3 Lund,  SE Se-22467
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-24
Decision Date2022-05-06

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