510(k) K150873

CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System by Accuray Incorporated — Product Code IYE

K150873 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System". The FDA issued a decision of Substantially Equivalent on July 1, 2015. 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.