510(k) K082005

MODIFICATION TO HI-ART TREATMENT SYSTEM by Tomotherapy Incorporated — Product Code MUJ

K082005 is an FDA 510(k) premarket notification submitted by Tomotherapy Incorporated for the device "MODIFICATION TO HI-ART TREATMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 25, 2008. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Tomotherapy Incorporated has at least 5 other 510(k) clearances on record.