510(k) K232854

Leksell GammaPlan (LGP) by Elekta Solutions AB — Product Code IWB

K232854 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "Leksell GammaPlan (LGP)". The FDA issued a decision of Substantially Equivalent on February 8, 2024. 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.