510(k) K153570

Axxent Electronic Brachytherapy System Model 110 XP 1200 by Icad, Inc. — Product Code JAD

K153570 is an FDA 510(k) premarket notification submitted by Icad, Inc. for the device "Axxent Electronic Brachytherapy System Model 110 XP 1200". The FDA issued a decision of Substantially Equivalent on February 25, 2016. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Icad, Inc. has at least 10 other 510(k) clearances on record.