510(k) K213439

FlexBoardTM, EagleBoardTM, BreastBoard SXTM by Macromedics BV — Product Code IYE

K213439 is an FDA 510(k) premarket notification submitted by Macromedics BV for the device "FlexBoardTM, EagleBoardTM, BreastBoard SXTM". The FDA issued a decision of Substantially Equivalent on Jun 24, 2022. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Macromedics BV has at least 4 other 510(k) clearances on record.