510(k) K162670

RSM 1824C with RConsole1 by DRTECH Corporation — Product Code MUE

K162670 is an FDA 510(k) premarket notification submitted by DRTECH Corporation for the device "RSM 1824C with RConsole1". The FDA issued a decision of Substantially Equivalent on February 23, 2017. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. DRTECH Corporation has at least 10 other 510(k) clearances on record.