K253726
- 510(k) number
- K253726
- Device name
- uAngio AVIVA CX
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-08-21
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253726.pdf
Official FDA record: K253726
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.