K254205
- 510(k) number
- K254205
- Device name
- Zenition 30
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-08-07
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254205.pdf
Official FDA record: K254205
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.