Fujifilm Medical Systems USA has received an approvable letter from the U.S. Food and Drug Administration for its computed radiography for mammography (FCRm) device. Fuji hopes to become the first vendor to sell a CR-based digital mammography system in the U.S.
The letter indicates that the FDA has completed its review of the company's premarket approval (PMA) application and that the PMA is approvable, according to the Stamford, CT-based firm.
The product enables sites to conduct digital mammography with an existing analog mammography acquisition unit by adding a CR cassette to the system. It provides both an 18 x 24-cm and 24 x 30-cm field-of-view, 50-micron pixel sampling, and the company's proprietary dual-side reading technology, Fuji said.
The FCRm is already available in Europe, Asia, and Canada.
By AuntMinnie.com staff writers
May 31, 2006
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