
Cedars-Sinai Medical Center
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CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE is an FDA 510(k)-cleared medical device (K123433) manufactured by Cedars-Sinai Medical Center. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 2013. Regulation: 8.