510(k) K052325

CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY by Accuray Incorporated — Product Code MUJ

K052325 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY". The FDA issued a decision of Substantially Equivalent on September 14, 2005. 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.