510(k) K850543

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY by Atomic Energy of Canada — Product Code IWB

K850543 is an FDA 510(k) premarket notification submitted by Atomic Energy of Canada for the device "THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY". The FDA issued a decision of Substantially Equivalent on May 10, 1985. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Atomic Energy of Canada has at least 5 other 510(k) clearances on record.