FDA.report

510(k) K133993

Device
CAAS WORKSTATION
Applicant
PIE MEDICAL IMAGING
510(k) number
K133993
Product code
IZI  
Decision
Substantially Equivalent (SESE)
Decision date
2014-03-25
Date received
2013-12-26
Regulation
892.1600
Classification name
System, X-ray, Angiographic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Florie Daniels
Address
Philipsweg 1 Maastricht NL 6227 AJ 6227 AJ

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
08056304451194CAAS WorkstationPie Medical Imaging B.V.2016-09-27

Legacy Summary

summary

FDA Review

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