510(k) K062514

CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM by Accuray Incorporated — Product Code MUJ

K062514 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 September 28, 2006. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Accuray Incorporated has at least 10 other 510(k) clearances on record.