Fujifilm Medical Systems USA has submitted the final module of its premarket approval (PMA) application for digital breast tomosynthesis (DBT) to the U.S. Food and Drug Administration (FDA).
The submission is for an optional DBT software upgrade for the company's Aspire Cristalle digital mammography system. The DBT upgrade has been available since May 2013 in Europe, Asia, and Latin America; Aspire Cristalle is known as Amulet Innovality outside of the U.S.
Aspire Cristalle is currently available in the U.S. as a full-field digital mammography system. It features the company's hexagonal close pattern (HCP) detector pixel design for enhanced acquisition efficiency and low-dose performance, Fuji said.
