ARTIS icono (Ceiling Configuration)

ARTIS icono (Ceiling Configuration) is an FDA 510(k)-cleared medical device (K221516) manufactured by Siemens Medical Solutions USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 18, 2022. Regulation: 8.