K253752
- 510(k) number
- K253752
- Device name
- ARTIS genio floor; ARTIS icono.explore floor
- Applicant
- Siemens Medical Solutions USA, Inc. PA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-04-23
- Date received
- 2025-11-25
- 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: K253752.pdf
Official FDA record: K253752
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.