510(k) K211720

Planmed Clarity 2D, Planmed Clarify S by Planmed OY — Product Code MUE

K211720 is an FDA 510(k) premarket notification submitted by Planmed OY for the device "Planmed Clarity 2D, Planmed Clarify S". The FDA issued a decision of Substantially Equivalent on July 18, 2022. 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.