510(k) K042146

ROBOCOUCH PATIENT SUPPORT SYSTEM by Accuray Incorporated — Product Code JAI

K042146 is an FDA 510(k) premarket notification submitted by Accuray Incorporated for the device "ROBOCOUCH PATIENT SUPPORT SYSTEM". The FDA issued a decision of Substantially Equivalent on September 17, 2004. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Accuray Incorporated has at least 10 other 510(k) clearances on record.