FDA Approves Direct Digital X-Ray Detector
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FDA Approves Direct Digital X-Ray Detector

NEW YORK, NY -- November 25, 1997 -- The United States Food and Drug Administration (FDA) has approved Swissray International, Inc.’s direct X-ray detector, the AddOn-Bucky(TM). This makes Swissray the first company to obtain FDA approval for direct digital X-ray technology for general diagnostic purposes.

The AddOn-Bucky is able to convert X-ray information directly into a digital image which can be viewed on Swissray's SwissVision workstation in excellent diagnostic image quality within approximately 20 seconds. The SwissVision workstation also permits a multitude of postprocessing options. Swissray's direct digital technology is designed to replace conventional screen-film systems and phosphor imaging plate systems and marks the beginning of a new era in radiography.

The time-consuming, labor-intensive and costly film, cassette and imaging plate handling is eliminated. This permits a significant reduction of operating costs and increases the efficiency of radiology departments. Since the use of X-ray film and developer chemicals becomes unnecessary, the AddOn-Bucky also offers environmental advantages.

Swissray plans to market the AddOn-Bucky in the U.S. as part of its AddOn-Multi-System, a complete multifunctional digital X-ray systems which performs most general X-ray applications. FDA approval for the complete system is pending.

Digital imaging technology, such as computed tomography, nuclear medicine, magnetic resonance imaging, ultrasound, digital subtraction angiography and certain fluoroscope systems, has been in use for a number of years for specific diagnostic applications. But an estimated 70 percent of all diagnostic examination are still performed using conventional radiography with traditional screen-film systems. The AddOn-Bucky is the missing link for a fully digitized radiology department, and it will move the industry closer to the ultimate goal: filmless radiology.

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