CAAS Workstation
K-Number: K180019 · 2018-05-03
ApplicantPie Medical Imaging BV
Decision Date2018-05-03
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CAAS Workstation is a medical device manufactured by Pie Medical Imaging BV. It received FDA 510(k) clearance on 2018-05-03 under approval number K180019. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CAAS Workstation?
CAAS Workstation is a medical device that received FDA 510(k) clearance on 2018-05-03. It is manufactured by Pie Medical Imaging BV. The 510(k) number is K180019.
When was CAAS Workstation approved by the FDA?
CAAS Workstation received FDA 510(k) clearance on 2018-05-03, under approval number K180019.
What company makes CAAS Workstation?
CAAS Workstation is manufactured by Pie Medical Imaging BV.
What is the FDA product code for CAAS Workstation?
The FDA product code for CAAS Workstation is IZI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.