CAAS Workstation

System, X-ray, Angiographic

Pie Medical Imaging BV

The following data is part of a premarket notification filed by Pie Medical Imaging Bv with the FDA for Caas Workstation.

Pre-market Notification Details

Device IDK180019
510k NumberK180019
Device Name:CAAS Workstation
ClassificationSystem, X-ray, Angiographic
Applicant Pie Medical Imaging BV Philipsweg 1 Maastricht,  NL 6227 Aj
ContactAnnemiek Bouts
CorrespondentAnnemiek Bouts
Pie Medical Imaging BV Philipsweg 1 Maastricht,  NL 6227 Aj
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-02
Decision Date2018-05-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08056304454058 K180019 000
08056304454003 K180019 000
08056304454331 K180019 000
08056304454461 K180019 000
08056304455314 K180019 000

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