510(k) K993766

HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM by Helax AB — Product Code MUJ

K993766 is an FDA 510(k) premarket notification submitted by Helax AB for the device "HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 8, 1999. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Helax AB has at least 2 other 510(k) clearances on record.