Fujifilm has obtained approval from Health Canada for its computed radiography for mammography (FCRm1) system to be distributed throughout the country. This is a first for CR mammography, as the company’s system has passed the rigorous Class III approval in North America. The system is licensed as the Fuji Image Reader PROFECT CS in Canada, and the same system FujiFilm Medical Systems USA has pending pre-market approval by the FDA, the company said yesterday.
The FCRm system is a four cassette slot CR mammography reader providing both 18x24 cm and 24x30 cm field-of-view, as well as patented dual-side reading technology and 50-micron pixel sampling, which is one of the highest sampling rates of any digital x-ray system available. The FCRm system also offers the ability to perform mammography, general radiography, and pediatric imaging exams.
The CR for mammography system will be available through Fuji’s exclusive Canadian distributor of its medical imaging products, Christie Group Ltd.