CAAS QCA 3D

System, Image Processing, Radiological

PIE MEDICAL IMAGING B.V.

The following data is part of a premarket notification filed by Pie Medical Imaging B.v. with the FDA for Caas Qca 3d.

Pre-market Notification Details

Device IDK063344
510k NumberK063344
Device Name:CAAS QCA 3D
ClassificationSystem, Image Processing, Radiological
Applicant PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht,  NL 6216 Bx
ContactCarla De Vries
CorrespondentCarla De Vries
PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht,  NL 6216 Bx
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-06
Decision Date2006-11-28
Summary:summary

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