510(k) K060912

MODIFICATION TO: HI-ART SYSTEM by Tomotherapy Incorporated — Product Code IYE

K060912 is an FDA 510(k) premarket notification submitted by Tomotherapy Incorporated for the device "MODIFICATION TO: HI-ART SYSTEM". The FDA issued a decision of Substantially Equivalent on April 19, 2006. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Tomotherapy Incorporated has at least 5 other 510(k) clearances on record.