Women's Health Weekly
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Diagnostics
Company submits PMA for CR mammography
July 7th, 2005
FUJIFILM Medical Systems USA, Inc., recently submitted the final module of its premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the approval of Fuji Computed Radiography for Mammography (FCRm). Fuji is seeking approval for its mammography software, which will enable the technologist console, known as the Imaging and Information Processor, and ClearView-CS, a multiplate computed radiography (CR) reader currently 510(k)-cleared for general radiography, to process digital mammography exams. The 510(k)-cleared ClearView-CS is a multiplate reader featuring Fuji's patented dual-side reading technology and 50-micron...
Source: Women's Health Weekly (2005-07-07)
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