510(k) K241572

ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) by Siemens Medical Solutions USA, Inc. — Product Code OWB

K241572 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)". The FDA issued a decision of Substantially Equivalent on October 22, 2024. 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.