3MENSIO WORKSTATION

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 3mensio Workstation.

Pre-market Notification Details

Device IDK120367
510k NumberK120367
Device Name:3MENSIO WORKSTATION
ClassificationSystem, Image Processing, Radiological
Applicant PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht,  NL 6216 Bx
ContactFlorie Daniels
CorrespondentFlorie Daniels
PIE MEDICAL IMAGING B.V. BECANUSSTRAAT 13 D Maastricht,  NL 6216 Bx
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-06
Decision Date2012-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304451224 K120367 000
08056304453495 K120367 000

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