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FDA approves Carestream's computed radiography mammography system

This article was originally published in Clinica

Executive Summary

The US FDA has granted premarket approval (PMA) for Carestream Health's Directview computed radiography (CR) system for mammography. The device enables conventional film-based mammography X-ray systems to be upgraded to digital mammography without having to replace existing X-ray equipment. "This makes it a very economic way to transition to digital [mammography]," Carestream told Clinica. The Rochester, New York-based firm has sold the CR mammography feature in Europe, Asia, Japan and Latin America since 2005, and it has also been available in Canada since 2007. The FDA recently reclassified full field digital mammography systems as medium-risk, rather than high-risk devices. This means products can now be approved under the less strenuous 510(k) process (, 5 November 2010).






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