KODAK DirectView CR Mammography System - P080018
FDA Approved on November 3rd, 2010, the product is manufactured by Carestream Health – a subdivision of Kodak
This medical device is a mammography system that utilizes the Kodak Directview CR Mammography Cassette. It utilizes an X-ray generator to produce mammography images on both hard copy (printed on film) and soft copy (digital image format).
The device is used for diagnosis in mammography but also has the indication for screening (i.e. for cancer, abnormalities, etc).
Note: Since the FDA Approval of this product the FDA has come out with less stringent regulations for submitting applications. They are now accepting 510(k) applications for CR Mammography units that have appropriate medical device predicats.
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