Eastman Kodak Health Group of Rochester, NY, has filed an application with Health Canada for regulatory clearance of its computed radiography (CR) system for mammography.
The filings are part of Kodak's plan to obtain approval in Canada for its Kodak DirectView CR mammography feature for its CR 850/950/975 systems.
Kodak already has submitted the final module of a premarket approval (PMA) to the U.S. Food and Drug Administration for approval of its CR system for mammography. Clinical trials were conducted at several sites in the U.S. and Canada.
Kodak currently is selling its CR mammography product in Europe, Asia, Japan, and Latin America.
By AuntMinnie.com staff writers
December 19, 2006
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