On May 30, FujiFilm Medical Systems (Stamford, CT) received a letter from the FDA regarding its full-field digital mammography system, indicating that the FDA’s pre-market analysis is complete and the system is approvable.
Fuji’s computed radiography for mammography is different from other digital mammography systems on the market because it does not require full replacement of a facility’s existing mammography acquisition unit. In addition to lowering conversion costs, Fuji expects that the new system will result in savings for sites that perform both mammograms and general radiography examinations by providing multi-purpose capability.
The new system will also provide an 18 x 24 cm and a 24 x 30 cm field of view, 50-micron pixel sampling, and dual-side reading technology for increased dose efficiency.