510(k) K211725

Senographe Pristina by GE Healthcare — Product Code MUE

K211725 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "Senographe Pristina". The FDA issued a decision of Substantially Equivalent on August 6, 2021. 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 Healthcare has at least 10 other 510(k) clearances on record.