CardioVision
K-Number: K251293 · 2025-11-21
ApplicantIcardio.Ai
Decision Date2025-11-21
Product CodeQUO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CardioVision is a medical device manufactured by Icardio.Ai. It received FDA 510(k) clearance on 2025-11-21 under approval number K251293. The device is classified under product code QUO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CardioVision?
CardioVision is a medical device that received FDA 510(k) clearance on 2025-11-21. It is manufactured by Icardio.Ai. The 510(k) number is K251293.
When was CardioVision approved by the FDA?
CardioVision received FDA 510(k) clearance on 2025-11-21, under approval number K251293.
What company makes CardioVision?
CardioVision is manufactured by Icardio.Ai.
What is the FDA product code for CardioVision?
The FDA product code for CardioVision is QUO.
Other Devices by Icardio.Ai
Related Devices (Code: QUO)
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.