510(k) K100714

CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 by Cedars-Sinai Medical Center — Product Code KPS

K100714 is an FDA 510(k) premarket notification submitted by Cedars-Sinai Medical Center for the device "CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01". The FDA issued a decision of Substantially Equivalent on Apr 1, 2011. 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.