510(k) K014033

EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS by Syntermed, Inc. — Product Code KPS

K014033 is an FDA 510(k) premarket notification submitted by Syntermed, Inc. for the device "EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS". The FDA issued a decision of Substantially Equivalent on Feb 22, 2002. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Syntermed, Inc. has 13 other 510(k) clearances on record.