AIRO Computed Tomography (CT) X-ray System

AIRO Computed Tomography (CT) X-ray System is an FDA 510(k)-cleared medical device (K160126) manufactured by Mobius Imaging. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 18, 2016. Regulation: 8.