CAAS MR 4D Flow
K-Number: K162376 · 2016-12-08
ApplicantPie Medical Imaging BV
Decision Date2016-12-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CAAS MR 4D Flow is a medical device manufactured by Pie Medical Imaging BV. It received FDA 510(k) clearance on 2016-12-08 under approval number K162376. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CAAS MR 4D Flow?
CAAS MR 4D Flow is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Pie Medical Imaging BV. The 510(k) number is K162376.
When was CAAS MR 4D Flow approved by the FDA?
CAAS MR 4D Flow received FDA 510(k) clearance on 2016-12-08, under approval number K162376.
What company makes CAAS MR 4D Flow?
CAAS MR 4D Flow is manufactured by Pie Medical Imaging BV.
What is the FDA product code for CAAS MR 4D Flow?
The FDA product code for CAAS MR 4D Flow is LLZ.
Other Devices by Pie Medical Imaging BV
Related Devices (Code: LLZ)
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.