510(k) K222047

Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) by Elekta Solutions AB — Product Code IWB

K222047 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)". The FDA issued a decision of Substantially Equivalent on October 26, 2022. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Elekta Solutions AB has at least 10 other 510(k) clearances on record.