510(k) K123433

CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE by Cedars-Sinai Medical Center — Product Code KPS

K123433 is an FDA 510(k) premarket notification submitted by Cedars-Sinai Medical Center for the device "CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE". The FDA issued a decision of Substantially Equivalent on Feb 26, 2013. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Cedars-Sinai Medical Center has 4 other 510(k) clearances on record.