ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno— 510(k) K254173
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K254173 for ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno, Substantially Equivalent on 2026-04-24. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's record names four systems: ARTIS icono floor, ARTIS icono biplane, ARTIS icono ceiling, and ARTIS pheno. All four are filed under product code OWB (Interventional Fluoroscopic X-Ray System).
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Siemens Medical Solutions USA filed from Malvern, Pennsylvania. The record shows 122 calendar days from receipt to decision (December 23, 2025 to April 24, 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.