510(k) K122951

XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110 by Icad, Inc. — Product Code JAD

K122951 is an FDA 510(k) premarket notification submitted by Icad, Inc. for the device "XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110". The FDA issued a decision of Substantially Equivalent on January 17, 2013. 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.