Fujifilm Medical Systems USA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Aspire HD flat-panel full-field digital mammography (FFDM) system.
Aspire HD features a proprietary detector that uses dual-layer amorphous selenium (a-Se) and Fuji's direct optical switching (DOS) technology, which combines with the company's 50-µm resolution for enhanced visualization.
The DOS technology eliminates the need for thin-film transistors (TFTs), which are commonly used in flat-panel FFDM systems currently on the market. The new technology enables what Fuji calls direct image transfer, which produces less noise and the potential to reduce dose, the company said.
The clearance means that Fuji can now offer mammography systems using both flat-panel digital radiography and computed radiography approaches.
