Artemis, Artemis TPO, Artemis MX

Artemis, Artemis TPO, Artemis MX is an FDA 510(k)-cleared medical device (K222222) manufactured by Eigen. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 11, 2023. Regulation: 8.