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FDA Approval for Fujifilm's FDR AcSelerate
| Company News - FUJIFILM Medical Systems USA, Inc. |
FUJIFILM Medical Systems USA received Food and Drug Administration (FDA) 510(k) approval for Fuji Digital Radiography (FDR) AcSelerate system, making it available for sale in the U.S.
FUJIFILM Medical Systems USA is pleased to announce that Food and Drug Administration (FDA) 510(k) approval has been received for the Fuji Digital Radiography (FDR) AcSelerate system, making it available for sale in the U.S. A fully automated digital table and upright system, the FDR AcSelerate produces images of unprecedented quality in comparison to other general radiographic systems*. It also includes special design elements and fast image cycle times that will help imaging departments increase efficiency and maximize productivity.
The latest addition to FUJIFILM Medical Systems extensive and world-leading line of DR systems, the FDR AcSelerate is the only general radiography system available today using a direct image capture technology. This amorphous selenium technology, coupled with Fujifilm's unparalleled advanced image processing experience, produce images of outstanding clarity and sharpness with superior contrast resolution for increased diagnostic confidence. The FDR AcSelerate has also proven to provide the potential for dose reduction, and a dose area product meter (DAP) is available so physicians can monitor patient dose per exam and total dose per study.
"The importance of image quality to providing the best possible patient care cannot be underestimated, so when Fujifilm developed the FDR AcSelerate we chose to design our own detector with superior physical properties to provide radiologists with images of optimal quality," explained Penny Maier, Fujifilm's Director of Marketing, Imaging Systems. "There's a reason that Fujifilm has been the world leader in digital x-ray for years, and with innovative products like the FDR AcSelerate we're confident that we'll remain the leader for many years to come," continued Maier.
The FDR AcSelerate is already installed at Swedish Covenant Hospital (SCH), Chicago, IL, where a clinical evaluation of the unit has taken place.
"We are thrilled to be the first North American install of AcSelerate," said Bradley Carlton, Director of Radiology at Swedish Covenant. "AcSelerate's direct digital capture technology lives up to its image quality claims which is key to radiologist satisfaction. And our technologists love the automated positioning features to help them maximize our patient throughput."
The intuitive design of the FDR AcSelerate enables technologists to work more efficiently, departments to be more productive, and patients to have reduced wait times. A fully automated table and upright system, it can be properly positioned for most any general radiography exam with just the touch of a button. Additionally, with a lightweight ergonomic design, AcSelerate takes less effort to position than traditional systems. The FDR AcSelerate provides image preview in 2 seconds with cycle times of only 4 seconds, and the new FDX Console workstation is now configured to alert technologists when exams are ready to expose.
The FDR AcSelerate will be upgradeable for tomosynthesis and energy subtraction; both applications are expected to be available later this year. Both require FDA 510(k) clearance.
To provide facilities with a more in-depth look at the product, FUJIFILM Medical Systems is sponsoring a Web cast on Wednesday, March 3, 2010. Titled "Virtual Test Drive: the FDR AcSelerate," this web cast will enable participants to view a demonstration of the product and gain a better understanding of the clinical benefits of the system, while also having the opportunity to pose questions to a panel of experts who will be live to field inquiries. For more information about the FDR AcSelerate or to register for the Web event, visit AcSelerate.fujimed.com.
Source: FUJIFILM Medical Systems
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