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FDA Clears Canon CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera

Canon USA, a provider in medical imaging, has received 510(k) clearance from FDA for the CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera that allows users 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.

Canon’s EOS camera technology, with its 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.

Canon said that 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 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.

Tsuneo Imai, senior director and general manager of medical systems division at Canon USA, said: “Canon has been a pioneer and leader in the field of retinal imaging since 1976. 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.”