FUJIFILM submits Aspire HD FFDM system 510(k) application to FDA for marketing clearance

FUJIFILM Medical Systems U.S.A., Inc. today announced the submission to the United States Food and Drug Administration (FDA) of its 510(k) application for marketing clearance of its new Aspire™ HD Full Field Digital Mammography (FFDM) system.  As a result of the down-classification of FFDM technologies by the FDA, Aspire HD is expected to be cleared in the near future.

A significant advantage of Fujifilm's Aspire HD FFDM system will be the exceptional image quality that provides remarkably enhanced detail of potential abnormalities. This is made possible in part by the system's 50 micrometre pixel resolution, the highest in the industry, along with Image Intelligence™, Fujifilm's proprietary image processing technology. Additionally, Aspire HD has a proprietary detector that uses the industry's only dual layer amorphous selenium design, coupled with Fujifilm's innovative Direct Optical Switching (DOS) technology. While these advancements significantly enhance image quality, they also decrease electronics image noise and heat which results in a more durable and, reliable system that facilities can depend on.

"We have good reason to be confident in the Aspire HD," says David Hotchkiss, Director, Product Marketing, Modality Solutions for Fujifilm. "The radiologists who are already using this system abroad have confirmed that the image quality is exceptional and we know it will exceed the expectations of the radiologists and technologists in the U.S. We expect that the Aspire HD will raise the bar for performance and reliability in mammography screening."