510(k) K010821

ECHOSEED/IODINE-125 SEEDS, MODEL 6733 by Medi-Physics Inc. Dba Nycomed Amersham Imaging — Product Code KXK

K010821 is an FDA 510(k) premarket notification submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging for the device "ECHOSEED/IODINE-125 SEEDS, MODEL 6733". The FDA issued a decision of Substantially Equivalent on April 11, 2001. The device falls under product code KXK (Source, Brachytherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5730. Medi-Physics Inc. Dba Nycomed Amersham Imaging has at least 8 other 510(k) clearances on record.