News | November 18, 2010

FDA Approval Granted for CR Mammography System

November 19, 2010 — The U.S. Food and Drug Administration (FDA) has given final approval for the Directview computed radiography (CR) system for mammography.

Carestream Health has begun commercial distribution of the system in the United States. The Carestream Directview CR mammography feature captures mammography images digitally and can be used in the same clinical applications as traditional screen-film mammography systems. The company has been selling its CR mammography system in Europe, greater Asia, Japan, Latin America and Canada for several years and has installed thousands of systems in clinics, breast imaging centers and hospitals of all sizes.

Carestream Health’s CR mammography system received premarket approval under the FDA’s class III standards. These are the FDA’s most stringent requirements and require extensive scientific and regulatory evidence that the device is safe and effective before it can be placed on the market.

The FDA has reclassified new full-field digital mammography (FFDM) systems under class II controls, which require only that the product be substantially equivalent to a currently marketed device. This reclassification will allow Carestream Health to more rapidly bring new enhancements to the radiology market.

Carestream Health’s mammography option is available when purchasing a new Carestream CR system or as an upgrade to installed models. It can be used for both general radiography and mammography exams.

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