510(k) K102650

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM by Accuray Incorporated — Product Code IYE

K102650 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 17, 2010. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Accuray Incorporated has at least 10 other 510(k) clearances on record.