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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: KODAK DirectView CR Mammography System
PMA Applicant: Carestream Health, Inc.
Address: 150 Verona Street, Rochester, NY 14608
Approval Date: November 3, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080018a.pdf
What is it? The KODAK DirectView CR Mammography System consists of the KODAK DirectView CR Mammography Cassette with EHR-M Screen designed to fit into the Bucky device of standard mammography x-ray equipment, and the KODAK DirectView CR Mammography Feature Software is designed to recognize the CR cassette and scan it to produce digital mammographic images. The KODAK DirectView CR Mammography System and a dedicated mammography x-ray machine produce hardcopy and soft copy digital mammographic images.
How does it work? KODAK DirectView CR Mammography is designed to be used with the KODAK DirectView CR Mammography System. The KODAK CR Mammography Cassette with EHR-M Screen captures a latent image which is extracted by laser scanning, converted to digital data, and processed by software to produce the final digital image for diagnostic interpretation and archiving.
When is it used? The device is used in screening and diagnosis of breast cancer, the same clinical applications as traditional screen-film and full-field digital mammographic systems.
What will it accomplish? The KODAK DirectView CR Mammography system has been shown to be effective in the detection of breast cancer and other breast abnormalities.
When should it not be used? There are no known contraindications. Warnings and precautions can be found in the device labeling.
Additional information: Summary of Safety and Effectiveness and labeling are available online: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p080018