Fujifilm Medical Systems USA has submitted 510(k) application to the US Food and Drug Administration (FDA) for marketing clearance of its new Aspire HD Full Field Digital Mammography (FFDM) system.
Fujifilm’s Aspire HD FFDM system provides the enhanced image quality that provides details of potential abnormalities.
The system has 50 micrometre pixel resolution, along with Image Intelligence, Fujifilm’s proprietary image processing technology.
Additionally, Aspire HD has a proprietary detector that uses the dual layer amorphous selenium design, coupled with Fujifilm’s innovative Direct Optical Switching (DOS) technology.
Fujifilm Modality Solutions Product Marketing director David Hotchkiss said the radiologists who are already using this system abroad have confirmed that the image quality is exceptional and they know it will exceed the expectations of the radiologists and technologists in the US.