Kodak looks to gain US clearance for CR (computed radiography) digital mammography technology:
This article was originally published in Clinica
Executive Summary
Eastman Kodak is seeking US FDA marketing clearance to add mammography capabilities to its computed radiography (CR) technology. The optional feature, which was introduced earlier this year for use on the company's DirectView CR 850, CR 950 and CR 975 systems in Europe, Asia, Japan and Latin America, is designed to offer the sharp and detailed images required for mammography. Kodak said its submission with the FDA related to information on the manufacturing of its CR system and on analytical tests the system has undergone. The company is currently conducting clinical trials of its digital mammography system at several sites in the US and Canada.
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