K251520
- 510(k) number
- K251520
- Device name
- Cios Alpha; Cios Flow
- Applicant
- Siemens Medical Solutions USA, Inc. PA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-07-09
- Date received
- 2025-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251520.pdf
Official FDA record: K251520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.