K232420
- 510(k) number
- K232420
- Device name
- Zenition 30
- Applicant
- Philips Medical Systems Nederland B.V. NL
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-02-16
- Date received
- 2023-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K232420.pdf
Official FDA record: K232420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.