Non-mydriatic retinal camera receives 510(k) clearance

December 14, 2010

The FDA has given 510(k) clearance to a non-mydriatic retinal camera (CR-2, Canon U.S.A.).

Lake Success, NY-The FDA has given 510(k) clearance to a non-mydriatic retinal camera (CR-2, Canon U.S.A.).

The camera’s 33-pound weight eases installation and transportation when needed, according to the company. The control panel is illuminated to enable medical staff to navigate operations in darkened rooms. The camera’s white LED lamp uses less power than a xenon tube and lasts about twice as long, which can help to reduce energy costs in medical facilities.

“Obtaining FDA clearance . . . helps reaffirm our commitment to eye-care professionals by instituting superb imaging technology and, in turn, contributing to the quality care of their patients,” said Tsuneo Imai, senior director and general manager, medical systems division, Canon U.S.A.

The camera is available for purchase through authorized Canon dealers.