510(k) K260087

Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright by GE Medical Systems SCS — Product Code MUE

K260087 is an FDA 510(k) premarket notification submitted by GE Medical Systems SCS for the device "Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright". The FDA issued a decision of Substantially Equivalent on March 24, 2026. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. GE Medical Systems SCS has at least 10 other 510(k) clearances on record.