Retinal camera receives 510(k) clearance

Lake Success, NY-A digital nonmydriatic retinal camera (CR-2 Plus, Canon U.S.A., Inc.) has received 510(k) clearance from the FDA and is available for purchase through authorized dealers.

The action brings the company “one step closer to improving eye exam efficiency and eventually leading to the early prevention and treatment of vision-threatening diseases,” said Tsuneo Imai, senior director and general manager of the medical systems division of Canon U.S.A.
The camera enables fundus autofluorescence photography in a non-mydriatic mode that monitors macular waste materials and delivers both red-free and cobalt digital filters to aid in evaluating the vascular and nerve fiber layers. The device also includes 18 megapixel autofocus technology and low-flash intensity, designed to minimize pupil constriction while shortening the time required for taking multiple pictures. Additionally, its software (Retinal Imaging Control Software, Canon) allows images to be captured, processed, and sent as digital files to a permanent storage database or printed through compatible equipment.

For more articles in this issue of Ophthalmology Times eReport, click here.