510(k) K152488

Onrad Treatment System by Accuray Incorporated — Product Code MUJ

K152488 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "Onrad Treatment System". The FDA issued a decision of Substantially Equivalent on September 28, 2015. 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.