Fujifilm has submitted to the FDA the final module of its pre-market approval application for digital breast tomosynthesis as an optional software upgrade for the Aspire Cristalle digital mammography system. Aspire Cristalle, available in the United States as a full-field digital mammography system, features Fujifilm’s hexagonal close-pattern-detector pixel design.
The system is engineered for higher acquisition efficiency and enhances detail for improved low-dose performance, as compared to conventional square pixel design. Sharper images and a gentler dose for patients is the result.
Available since May 2013 in Europe, Asia, and Latin America, the optional digital breast tomosynthesis upgrade for the Aspire Cristalle system is called Amulet Innovality in these parts of the world.
“Today marks another milestone in Fujifilm’s mission to bring innovative digital breast tomosynthesis technology to physicians and women across America,” says Rob Fabrizio, director of strategic marketing for digital radiography and women’s health at Fujifilm.
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