510(k) K254173

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno by Siemens Medical Solutions USA, Inc. — Product Code OWB

K254173 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno". The FDA issued a decision of Substantially Equivalent on April 24, 2026. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.