QIR Suite
K-Number: K211611 · 2022-09-30
Decision Date2022-09-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
QIR Suite is a medical device manufactured by Casis Cardiac Simulation & Imaging Software. It received FDA 510(k) clearance on 2022-09-30 under approval number K211611. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QIR Suite?
QIR Suite is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Casis Cardiac Simulation & Imaging Software. The 510(k) number is K211611.
When was QIR Suite approved by the FDA?
QIR Suite received FDA 510(k) clearance on 2022-09-30, under approval number K211611.
What company makes QIR Suite?
QIR Suite is manufactured by Casis Cardiac Simulation & Imaging Software.
What is the FDA product code for QIR Suite?
The FDA product code for QIR Suite is QIH.
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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.