ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno is an FDA 510(k)-cleared medical device (K254173) 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 23, 2026. Regulation: 8.