ARTIS genio floor; ARTIS icono.explore floor

ARTIS genio floor; ARTIS icono.explore floor is an FDA 510(k)-cleared medical device (K253752) 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 April 22, 2026. Regulation: 8.