CAAS MR 4D Flow

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 Mr 4d Flow.

Pre-market Notification Details

Device IDK162376
510k NumberK162376
Device Name:CAAS MR 4D Flow
ClassificationSystem, Image Processing, Radiological
Applicant PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht,  NL 6227 Aj
ContactAnnemiek Bouts
CorrespondentAnnemiek Bouts
PIE MEDICAL IMAGING B.V. PHILIPSWEG 1 Maastricht,  NL 6227 Aj
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-24
Decision Date2016-12-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304453051 K162376 000
08056304453433 K162376 000

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