510(k) K081066

BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 by Medi-Physics, Inc., Dba GE Healthcare — Product Code IWG

K081066 is an FDA 510(k) premarket notification submitted by Medi-Physics, Inc., Dba GE Healthcare for the device "BRACHYTHERAPY SOURCE DEVICE, MODEL 9011". The FDA issued a decision of Substantially Equivalent on May 5, 2008. The device falls under product code IWG (Seed, Isotope, Gold, Titanium, Platinum), a Class II device regulated under 21 CFR 892.5730.