Emory Cardiac Toolbox 4.3

Emory Cardiac Toolbox 4.3 is an FDA 510(k)-cleared medical device (K223422) manufactured by Syntermed. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 2023. Regulation: 8.