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

FDA cleared the ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno from Siemens Medical Solutions USA, Inc. on Apr 24, 2026 under K254173, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 23, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Siemens Medical Solutions USA, Inc. has 8 other decisions in the tracker over the last 12 months: K253786 (syngo.CT Coronary Cockpit), K253678 (MAMMOMAT B.brilliant (11372950)), K260844 (ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System), K261315 (Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family).