This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Fuji Computed Radiography Mammography Suite (FCRMS)
PMA Applicant: FujiFilm Medical System U.S.A., Inc.
Address: 419 West Avenue; Stamford, Connecticut 06902-6300
Approval Date: July 10, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050014a.pdf
What is it? The FCRMS is software installed in an already-FDA-cleared Fuji Computed Radiography (FCR) system to form the Fuji Computed Radiography mammography (FCRm) device. The FCRm and a dedicated mammography x-ray machine produce hardcopy and soft copy digital mammographic images.
How does it work? The FCRm system acquires breast images using Fuji imaging plates in conjunction with a dedicated mammography x-ray machine. The images are then read by a Fuji image reader which can be viewed using an FDA cleared display system or a film printer.
When is it used? The device is used in screening and diagnosis of breast cancer just as a conventional analog mammography system.
What will it accomplish? The FCRm has been shown to be effective in the detection of breast cancer and other breast abnormalities.
Additional information: Summary of Safety and Effectiveness Data and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050014