510(k) K771096

TELHTHERAPY SIMULATOR AECL-CP, G-3200 by Atomic Energy of Canada — Product Code JAA

K771096 is an FDA 510(k) premarket notification submitted by Atomic Energy of Canada for the device "TELHTHERAPY SIMULATOR AECL-CP, G-3200". The FDA issued a decision of Substantially Equivalent on July 1, 1977. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Atomic Energy of Canada has at least 5 other 510(k) clearances on record.