510(k) K120859

PRE-LOADED GOLD VISICOIL CK MARKER by Radiomed Corporation — Product Code KXK

K120859 is an FDA 510(k) premarket notification submitted by Radiomed Corporation for the device "PRE-LOADED GOLD VISICOIL CK MARKER". The FDA issued a decision of Substantially Equivalent on Apr 19, 2012. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Radiomed Corporation has 4 other 510(k) clearances on record.