Fuji Aspire HD Gets FDA Nod
Fujifilm Medical Systems USA yesterday announced that it 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. The clearance enables the company to offer mammography systems using flat-panel digital radiography and computed radiography approaches alike.
Aspire HD has a proprietary detector that utilizes dual-layer amorphous selenium (a-Se) and Fuji's direct optical switching (DOS) technology. The latter combines with Fuji’s 50-µm resolution to afford enhanced visualization, according to the compay.
Meanwhile, the DOS technology eliminates the need for the thin-film transistors (TFTs) commonly found in currently available flat-panel FFDM systems. The new technology enables a “direct image transfer” process that produces less noise, according to the company.
To read the press release, click here: http://www.prnewswire.com/news-releases/fujifilms-aspire-hd-receives-fda-clearance-129642078.html