Canon receives FDA 510(k) clearance for CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera

Canon U.S.A., Inc., a leader in medical imaging, today announced the Canon CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

“Canon's latest advancement, the CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera, will help eyecare professionals provide comprehensive, high-end care to their patients by providing outstanding digital imaging technology.”

The CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera is Canon's first fully hybrid digital retinal camera with both mydriatic and non-mydriatic modes. With one-touch, the operator can automatically switch between mydriatic and non-mydriatic modes, utilizing different functions within seconds and performing several concurrent ocular tests.

The Canon CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera allows the user to take one-shot Fundus Autofluorescence (FAF) photography in a standard configuration, for both mydriatic and non-mydriatic modes. FAF is the occurrence of autofluorescence in macular waste, particularly Lipofuscin. Examinations that check and monitor autofluorescent waste material are a key step in age related muscular degeneration detection. Using the non-mydriatic mode not only saves time and resources, it also can make the diagnostic procedure more comfortable for the patient.

"Canon has been a pioneer and leader in the field of retinal imaging since 1976," said Tsuneo Imai, senior director and general manager, Medical Systems Division, Canon U.S.A. "Canon's latest advancement, the CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera, will help eyecare professionals provide comprehensive, high-end care to their patients by providing outstanding digital imaging technology."

Canon's EOS camera technology, with its renowned image processing capabilities, is adapted exclusively for medical use in the CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera, providing up to 15.1-megapixel resolution. The CX-1 is capable of delivering clear and detailed diagnostic images for virtually immediate review. The single onboard digital camera handles five different photography modes with ease, including non-mydriatic FAF, Color, Red-free, Cobalt and Fluorescein angiography photography.

The Retinal Imaging Control Software that comes with the CX-1 puts tools for comprehensive study management, image capture controls and easy viewing at the user's fingertips. The intuitive graphical interface is simple and straightforward to use. The PC-based software provides quick input and access to information and images required to assist in patient diagnosis, and data can be easily saved to various external media.

The CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera joins Canon's complete line of total digital imaging solutions and workflow management solutions for ophthalmic professionals. The CX-1 became available March 29, 2010 through Canon authorized dealers.