510(k) K010682

HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM by Mds Nordion — Product Code MUJ

K010682 is an FDA 510(k) premarket notification submitted by Mds Nordion for the device "HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 5, 2001. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Mds Nordion has at least 8 other 510(k) clearances on record.