510(k) K110025

SECTRA MICRODOSE MAMMOGRAPHY by Sectra Imtec AB — Product Code MUE

K110025 is an FDA 510(k) premarket notification submitted by Sectra Imtec AB for the device "SECTRA MICRODOSE MAMMOGRAPHY". The FDA issued a decision of Substantially Equivalent on April 28, 2011. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Sectra Imtec AB has at least 4 other 510(k) clearances on record.