FDA cleared the ARTIS genio floor; ARTIS icono.explore floor from Siemens Medical Solutions USA, Inc. on Apr 23, 2026 under K253752, 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 Nov 25, 2025. The decision came 149 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).