ARTIS genio floor; ARTIS icono.explore floor— 510(k) K253752
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K253752 for ARTIS genio floor; ARTIS icono.explore floor, Substantially Equivalent on 2026-04-23. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's record names two systems, ARTIS genio floor and ARTIS icono.explore floor, both filed under product code OWB (Interventional Fluoroscopic X-Ray System). The record doesn't describe either one beyond its name.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Siemens Medical Solutions USA filed from Malvern, Pennsylvania. The decision came 149 calendar days after FDA received it (November 25, 2025 to April 23, 2026).
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code OWB
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.