uAngio AVIVA CX— 510(k) K253726
Substantially EquivalentShanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearance K253726 for uAngio AVIVA CX, Substantially Equivalent on 2026-08-21. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.
Summary
Shanghai United Imaging Healthcare filed the uAngio AVIVA CX under product code OWB, interventional fluoroscopic x-ray systems. No other model numbers are listed.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
United Imaging filed from Shanghai, China. The decision came 270 calendar days after FDA received it (November 24, 2025 to August 21, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code OWB
view allMore clearances from Shanghai United Imaging Healthcare Co., Ltd.
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.