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The Canon Inc. (CAJ) CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera Receives FDA Clearance


4/5/2010 7:10:39 AM

LAKE SUCCESS, N.Y.--(BUSINESS WIRE)--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)1.

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.

For more information about Canon ophthalmic devices and solutions, please go to www.usa.canon.com/eye-care.

About Canon U.S.A., Inc.

Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions. Its parent company, Canon Inc. (NYSE:CAJ - News), a top patent holder of technology, ranked fourth overall in the U.S. in 2009†, with global revenues of US $35 billion, is listed as number four in the computer industry on Fortune Magazine's World’s Most Admired Companies 2009 list, and is on the 2009 BusinessWeek list of "100 Best Global Brands." Canon U.S.A is committed to the highest levels of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. At Canon, we care because caring is essential to living together in harmony. Founded upon a corporate philosophy of Kyosei – "all people, regardless of race, religion or culture, harmoniously living and working together into the future" – Canon U.S.A supports a number of social, youth, educational and other programs, including environmental and recycling initiatives. Additional information about these programs can be found at www.usa.canon.com/kyosei. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss.

Specifications subject to change without notice.

All referenced product names, and other marks, are trademarks of their respective owners.

1FDA clearance does not in any way denote official FDA approval of this device.

†Based on weekly patent counts issued by United States Patent and Trademark Office.

Contact:

Canon U.S.A. Web site: http://www.usa.canon.com or Editorial: Canon U.S.A. Melissa Moritz, 516-328-4553 mmoritz@cusa.canon.com or For customer information: 1-800-970-7227

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