Critical Care Suite with Endotracheal Tube Positing AI algorithm

Critical Care Suite with Endotracheal Tube Positing AI algorithm is an FDA 510(k)-cleared medical device (K211161) manufactured by Ge Medical Systems, LLC. 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 28, 2021. Regulation: 8.