Icardio.Ai
Country not established
- Devices
- 2
What Icardio.Ai makes
Icardio.Ai develops AI-powered diagnostic tools for cardiac imaging, including CardioVision, a software solution for automated analysis of echocardiograms, and EchoMeasure, a tool for precise measurement and assessment of cardiac structures from ultrasound images.
The company’s portfolio is regulated under FDA Class II devices and includes products authorised via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
CardioVision Ref K251293
Regimes: 510(k) Registry: 510(k)EchoMeasure Ref K241430
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Icardio.Ai have in the registry?
The registry currently lists 2 devices for Icardio.Ai. Devices recorded under merged duplicate company entries are counted once.
Which registries list Icardio.Ai's devices?
Among its 2 most recently registered devices, Icardio.Ai has devices listed in FDA 510(k) (2 devices).
What risk classes do Icardio.Ai's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Icardio.Ai's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Icardio.Ai in the registry?
The most recently registered devices listed for Icardio.Ai include CardioVision and EchoMeasure.