Fujifilm Medical Systems USA has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for Aspire HD, a full-field digital mammography (FFDM) system based on digital radiography (DR) technology.
Aspire HD uses dual-layer amorphous selenium design, coupled with Fuji's direct optical switching (DOS) technology. The system features pixel resolution of 50 µm, which Fuji said would provide enhanced detail of abnormalities.
Fuji said it expects Aspire HD to be cleared in the near future, thanks to the down-classification of FFDM technologies by the FDA. Fuji already markets FFDM units based on computed radiography technology and has an installed base of more than 8,000 units worldwide.
