FUJIFILM Medical Systems USA, Inc. said Friday it has submitted the final module of its pre-market approval (PMA) application with the FDA for the approval of Fuji Computed Radiography for Mammography (FCR m). Fuji is seeking approval for its mammography software, which will enable the technologist console, known as the Imaging and Information Processor (IIP), and ClearView-CS, a multi-plate CR reader that is currently 510(k) cleared for general radiography, to process digital mammography exams. If approved, the system would be the first digital mammography system based on CR technology available for sale in the U.S.
The 510(k) cleared ClearView-CS is a multi-plate reader featuring Fuji's patented dual-side reading technology and 50-micron pixel sampling-which is one of the highest sampling rates of any digital x-ray system available, the company said. The reader is currently in use at more than 40 sites across the U.S.
When approved for mammography, the ClearView-CS will be used in conjunction with advanced image processing tools such as Fuji's Pattern Enhancement processing for Mammography (PEM), and will be known as the ClearView-CS m.
FCR m, a more cost-effective solution for digital mammography that currently used detector-based systems, is already in use in facilities in Europe, Asia and Australia.
The multi-plate design of the system's reader, which has throughput of up to 20 screening exams per hour, enables facilities to take up to three exam rooms digital for the cost of only one system, according to Fuji. Any patient imaged with screen film can be imaged using FCR m since both 18x24 cm and 24x30 cm detector sizes are available. And the ClearView-CS offers facilities the ability to multi-task between mammography and general radiography exams.
In initial U.S. clinical trials conducted at the Mayo Clinic, Rochester, Minn., and UCLA, Los Angeles, Calif., Fuji CR for Mammography allowed investigators to better visualize breast abnormalities in women with dense breasts. It also was used to acquire nearly one third of the images for the world's largest digital mammography investigation, ACRIN-DMIST - the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial. Results of this investigation are expected to be announced in the coming months.