510(k) K053485

THERATRON EQUINOX, MODELS 80 CM AND 100 CM by Mds Nordion, Inc. — Product Code IWB

K053485 is an FDA 510(k) premarket notification submitted by Mds Nordion, Inc. for the device "THERATRON EQUINOX, MODELS 80 CM AND 100 CM". The FDA issued a decision of Substantially Equivalent on March 9, 2006. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Mds Nordion, Inc. has at least 8 other 510(k) clearances on record.