STAMFORD, CT. - May 30, 2006 - FUJIFILM Medical Systems USA has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Fuji's computed radiography for mammography (FCRm), the world's leading full-field digital mammography system. This letter indicates that the FDA has completed its review of Fuji's Pre-Market Approval (PMA) application and that it is approvable.
"We are excited that the FDA has completed its review of our PMA application," said Andy Vandergrift, Fuji's National Marketing Manager, Women's Healthcare Imaging. "Facilities worldwide are already benefiting from FCRm's unique combination of image quality, flexibility, and practicality. We are pleased that we are one step closer to FDA approval so that facilities in the U.S. can implement this high performance, cost-effective solution."
Unlike all other digital mammography systems available today, Fuji's computed radiography for mammography does not require replacing the existing mammography acquisition unit. This significantly lowers conversion costs for facilities. Additionally, the FCRm reader will provide multi-purpose capability for both mammography and general radiography exams, delivering significant cost savings for sites that perform both exams.
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Also of note is the image quality of FCRm. The system will provide both an 18 x 24 cm and 24 x 30 cm field-of-view, 50-micron pixel sampling, and Fuji's patented dual-side reading technology that results in unprecedented levels of dose efficiency compared to traditional CR systems.
About FUJIFILM Medical Systems USA, Inc.
As one of the Fuji Photo Film family of companies with 70 years of imaging experience and almost $25 billion in sales, FUJIFILM Medical Systems is a leading provider of diagnostic imaging products and network systems to meet the needs of healthcare facilities today and well into the future. Fuji's family of Imaging Systems products and technologies-including digital x-ray, women's healthcare imaging, dry imagers, and conventional x-ray film and equipment-are tailored to suit many different applications for a variety of imaging environments. The pioneer of computed radiography (CR), Fuji remains the market leader in digital x-ray with products that are clinically proven and constantly evolving to set the standard in digital imaging innovation. Fuji is headquartered in Stamford, CT.
