Iscreen, LLC
Country not established
- Devices
- 1
What Iscreen, LLC makes
Iscreen, LLC manufactures the ISCREEN Vision Screener, a device designed for automated visual acuity and refractive error assessment in clinical settings.
The ISCREEN Vision Screener is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Iscreen Vision Screener Ref K010315
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Iscreen, LLC have in the registry?
The registry currently lists 1 device for Iscreen, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iscreen, LLC's devices?
Among its 1 most recently registered device, Iscreen, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Iscreen, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Iscreen, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iscreen, LLC in the registry?
The most recently registered devices listed for Iscreen, LLC include ISCREEN VISION SCREENER.