MEDRAD Stellant FLEX CT Injection System with Certegra Workstation

MEDRAD Stellant FLEX CT Injection System with Certegra Workstation is an FDA 510(k)-cleared medical device (K192370) manufactured by Bayer Medical Care, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2019. Regulation: 8.