510(k) K982937

MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER by Victoreen, Inc. — Product Code LHN

K982937 is an FDA 510(k) premarket notification submitted by Victoreen, Inc. for the device "MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER". The FDA issued a decision of Substantially Equivalent on November 19, 1998. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Victoreen, Inc. has at least 10 other 510(k) clearances on record.