510(k) K111299

AXXENT RADIATION SHIELD - RIGID by Xoft, an Icad Company — Product Code JAD

K111299 is an FDA 510(k) premarket notification submitted by Xoft, an Icad Company for the device "AXXENT RADIATION SHIELD - RIGID". The FDA issued a decision of Substantially Equivalent on July 20, 2011. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900.