K240224
- 510(k) number
- K240224
- Device name
- Zenition 90
- Applicant
- Philips Medical Systems Nederlands B.V. NL
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-05-22
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K240224.pdf
Official FDA record: K240224
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.