K252229
- 510(k) number
- K252229
- Device name
- BELLIGER ACE
- Applicant
- Genoray Co., Ltd. CN
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-04-02
- Date received
- 2025-07-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252229.pdf
Official FDA record: K252229
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.