510(k) K192317

Planmed Clarity 2D and Clarity S by Planmed OY — Product Code MUE

K192317 is an FDA 510(k) premarket notification submitted by Planmed OY for the device "Planmed Clarity 2D and Clarity S". The FDA issued a decision of Substantially Equivalent on October 23, 2020. The device falls under product code MUE (Full Field Digital, System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1715. Planmed OY has at least 10 other 510(k) clearances on record.