K251827
- 510(k) number
- K251827
- Device name
- Azurion R3.1
- Applicant
- Philips Medical Systems B.V. NL
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-10-24
- Date received
- 2025-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K251827.pdf
Official FDA record: K251827
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.