510(k) K160440

Leksell Gamma Knife Icon by Elekta Instrument AB — Product Code IWB

K160440 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "Leksell Gamma Knife Icon". The FDA issued a decision of Substantially Equivalent on April 20, 2016. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Elekta Instrument AB has at least 10 other 510(k) clearances on record.