Idx, LLC
Country not established
- Devices
- 1
What Idx, LLC makes
Idx, LLC makes the IDx-DR, an autonomous artificial intelligence system designed to detect diabetic retinopathy in retinal images.
The IDx-DR is a Class II medical device listed in the FDA 510(k) registry, and the company is based in the United States.
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
IDx-DR Ref DEN180001
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Idx, LLC have in the registry?
The registry currently lists 1 device for Idx, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Idx, LLC's devices?
Among its 1 most recently registered device, Idx, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Idx, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Idx, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Idx, LLC in the registry?
The most recently registered devices listed for Idx, LLC include IDx-DR.