K254173
- 510(k) number
- K254173
- Device name
- ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno
- Applicant
- Siemens Medical Solutions USA, Inc. PA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-04-24
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254173.pdf
Official FDA record: K254173
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.