ILUMIEN System with AptiVue Software version D.3

ILUMIEN System with AptiVue Software version D.3 is an FDA 510(k)-cleared medical device (K192267) manufactured by ABBOTT MEDICAL. 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 16, 2019. Regulation: 8.