The FDA has granted 510(k) clearance to a hybrid mydriatic/non-mydriatic digital retinal camera (CX-1, Canon).
Lake Success, NY
-The FDA has granted 510(k) clearance to a hybrid mydriatic/non-mydriatic digital retinal camera (CX-1, Canon).
The device is the company’s first fully hybrid digital retinal camera with both mydriatic and non-mydriatic modes and is designed to enable the operator to switch automatically between modes with one touch. The camera also is designed to allow the user to perform one-shot fundus autofluorescence (FAF) photography in a standard configuration, for both mydriatic and non-mydriatic modes. In addition to FAF modes, the single onboard digital camera handles color, red-free, and cobalt modes.
“Canon’s latest advancement . . . will help eye-care professionals provide comprehensive, high-end care to their patients by providing outstanding digital imaging technology,” said Tsuneo Imai, senior director and general manager, Medical Systems Division, Canon U.S.A.
Additionally, according to the company:
• The camera features proprietary technology adapted exclusively for medical use, providing up to 15.1-megapixel resolution.
• The camera is capable of delivering diagnostic images for virtually immediate review.
• The camera also comes with PC-based retinal imaging control software designed to put comprehensive study management, image capture controls, and easy viewing at the user’s fingertips. It includes a graphical interface that is designed to be intuitive, simple, and straightforward. The software is designed to provide quick input and access to information and images required to assist in patient diagnosis. Data can be saved to various external media.
The camera is available through authorized dealers.