Canon CXDI-31 Receives FDA Approval; World's First Portable Digital Radiography System is Available From Canon Medical Systems.

Business Editors, Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--Jan. 22, 2002

Lightweight Compact Sensor Allows Image Capture

From Virtually Any Angle

The Canon Digital Radiography CXDI-31 flat-panel cassette-type sensor, the world's first portable DR sensor that provides hospitals with the necessary portability to use with stretchers, gurneys and patient tables, has received FDA510(k) clearance and now is available from Canon Medical Systems.

The list price is $85,000 to retrofit from an existing Canon CXDI-22 DR system. Canon Medical Systems is a division of Canon U.S.A., Inc., which is a subsidiary of Canon Inc. (NYSE: CAJ).

Clinical testing of the compact and ultra-thin (weighing just 6.2 pounds; less than an inch thick) Canon CXDI-31 was completed at the Cleveland Clinic Foundation clinical radiology department and neo-natal ICU department. Images were presented to the industry at the 2001 Radiology Society of North America (RSNA) trade show last November.

The Canon CXDI-31 incorporates the company's breakthrough amorphous silicon (a-Si) technology to provide superior quality diagnostic images and effective on-demand network distribution of captured image data. Easy to set up and operate, technologists can capture an image from virtually any angle. If necessary, patients easily can hold the sensor to help medical personnel capture a proper image.

The Canon CXDI-31 operates similar to a conventional analog film cassette. Both permit X-rays from almost any angle without moving the patient to the sensor unit or film cassette. The key difference is the new digital system is filmless, instantaneously capturing and displaying images. Portability is useful in many medical situations, especially trauma imaging and neonatal, pediatric and orthopedic applications, and limited-mobility patients.

The Canon CXDI-31 has a flat-panel sensor that comprises a scintillator and an a-Si sensor plate to generate extremely high-quality, high-resolution radiographic images. X-rays that pass through a patient's body to the scintillator are converted into light that is "read" by the amorphous silicon plate, creating a 14-bit digital image, or 16,384 gray scales. The sensor features a groundbreaking 100-micron pixel pitch, realizing high-resolution imaging (approximately 6.5 million pixels) in a 9 x 11 format that makes the new Canon digital radiography appropriate for bone X-rays.

The Canon CXDI-31 is the latest addition to the company's line of leading-edge DR systems, which began with the 1998 launch of the Canon CXDI-11 digital radiography system (upright version) and the 2000 launch of the Canon CXDI-22 (digital bucky model). These Canon-developed systems, used by more than 350 locations worldwide, are widely recognized as reliable and cost-effective alternatives to traditional x-ray image capture devices.

As a supplement to the Canon CXDI-22, the Canon CXDI-31 enables X-rays to be taken of virtually any part of the body to meet effectively all diagnostic radiography demands. Canon DR systems are easy to use and provide scalability that permits multiple imaging units to be operated from a single control station.

When compared with conventional X-ray imaging systems and new computer radiography, the Canon CXDI digital radiography series has several significant advantages. X-ray images are confirmed on a preview monitor approximately three seconds after exposure. The ease of use and portability features contribute to improved health care efficiency. The technology streamlines the X-ray diagnostic imaging process by eliminating film processing and the loading/scanning of imaging plates.

Canon Medical Systems was formed in April 1999 to provide medical facilities with a single source from which to purchase both Canon's innovative Digital Radiography and PACS products.

Canon U.S.A., Inc. provides professional and consumer imaging solutions that give people the Know How to access the latest technology. The company's comprehensive product line includes networked multifunction devices; digital and analog copiers (color and black and white); printers, scanners, image filing systems, and facsimile machines; camcorders, cameras and lenses; and semiconductor, broadcast and medical equipment. Canon employs 12,000 people at more than 30 facilities throughout North, Central and South America and the Caribbean.

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