Fujifilm Submits 510(K) Application to FDA for Aspire(TM) HD FFDM System
STAMFORD, Conn., March 16, 2011 – 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(TM) 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(TM), 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.”
Fujifilm is the world leader in FFDM with more than 8000 systems installed worldwide. The company was the first to bring computed radiography- (CR) based FFDM to the U.S. market in 2006 and has been successfully serving the needs of hospitals and imaging centers with the Aspire ClearView-CSm and the Aspire ClearView-1m, multi- and single-imaging plate systems. “With FDA clearance of the Aspire HD, Fujifilm is expected to be the first and only vendor to provide both CR-and DR-based FFDM systems in the U.S., assuring that we have a solution that is right for any and every facility’s needs,” concludes Hotchkiss.
For more information about Fujifilm’s women’s health solutions, visit the company at the National Consortium of Breast Centers (NCBC) conference in Las Vegas, March 12 – 16, or the Society for Breast Imaging (SBI) meeting in San Antonio, Texas, May 18 – 21.
FUJIFILM Medical Systems U.S.A., Inc. is a leading provider of diagnostic imaging products and medical informatics solutions to meet the needs of healthcare facilities today and well into the future. From an unrivaled selection of digital x-ray systems, to the SynapseÃ‚® brand of PACS, RIS and cardiovascular products, to advanced women’s health imaging systems, Fujifilm has products that are ideal for any size imaging environment. FUJINON is a subsidiary of FUJIFILM Medical Systems U.S.A., Inc., and supplies technologically advanced endoscopes to the medical market. FUJIFILM Medical Systems U.S.A., Inc. is headquartered in Stamford, CT. For more information visit www.fujimed.com.
*The Aspire(TM) HD Full Field Digital Mammography (FFDM) system requires FDA 510(k) clearance and is not yet available for sale in the U.S.
Ã‚© 2011 FUJIFILM Medical Systems U.S.A., Inc.
SOURCE FUJIFILM Medical Systems U.S.A., Inc.