Optical Imaging, Ltd.
Country not established
- Devices
- 2
What Optical Imaging, Ltd. makes
Optical Imaging, Ltd. manufactures retinal imaging devices, including the Retinal Functional Imager (RFI) and its modified versions, designed to assess retinal function for diagnostic purposes.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Modification To Retinal Function Imager (Rfi) Ref K080180
Regimes: 510(k) Registry: 510(k)Retinal Functional Imager (Rfi) Ref K062416
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Optical Imaging, Ltd. have in the registry?
The registry currently lists 2 devices for Optical Imaging, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Optical Imaging, Ltd.'s devices?
Among its 2 most recently registered devices, Optical Imaging, Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Optical Imaging, Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Optical Imaging, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Optical Imaging, Ltd. in the registry?
The most recently registered devices listed for Optical Imaging, Ltd. include MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) and RETINAL FUNCTIONAL IMAGER (RFI).