510(k) K103485

SENOGRAPH DS, SENOGRAPH ESSENSTIAL by General Electric Company — Product Code MUE

K103485 is an FDA 510(k) premarket notification submitted by General Electric Company for the device "SENOGRAPH DS, SENOGRAPH ESSENSTIAL". The FDA issued a decision of Substantially Equivalent on October 6, 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. General Electric Company has at least 10 other 510(k) clearances on record.