Sterling Diagnostic Imaging Inc. (Greenville, SC) has received U.S. Food and Drug Administration (FDA) certification for its iiRAD(TM) operator console. This allows Sterling to market its own line of DirectRay(TM) direct-to-digital image x-ray equipment in the U.S. The digital flat-panel, image-capture technology directly captures and converts x-ray energy into a digital image, resulting in a higher resolution x-ray than conventional methods. Within seconds after exposure, DirectRay digital images are available for preview and diagnosis. Traditional screen-film technology often takes 15 minutes or more to develop and deliver. The iiRAD operator console controls the capturing and configuring images from the DirectRay detector array and array controller. The console, designed for fast, simple operation, serves as the user interface to x-ray generation equipment that acquires patient and exam data and routes images and information to printers, display, and storage devices. Sterling plans to commercialize two iiRAD x-ray systems in 1998--the iiRAD DR 1000C dedicated chest system and the iiRAD DR1000 general radiography system. Other systems are in development. Visit the company's web site at www.sterlingdi.com. E-mail: firstname.lastname@example.org.
As manufacturers add new technologies to their products, designing for compliance becomes more difficult. Prepare for the certification testing process. Otherwise, you increase the risk of discovering a safety issue after a product leaves the assembly line. That will cause significant time-to-market delays, be much costlier to fix, and damage your brand in the eyes of customers.
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