
Cedars-Sinai Medical Center
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CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE is an FDA 510(k)-cleared medical device (K112474) 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 September 22, 2011. Regulation: 8.