510(k) K837347

LINEAR ACCELERATOR THERAC 25 by Atomic Energy of Canada — Product Code IYE

K837347 is an FDA 510(k) premarket notification submitted by Atomic Energy of Canada for the device "LINEAR ACCELERATOR THERAC 25". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Atomic Energy of Canada has at least 5 other 510(k) clearances on record.