uWS-Angio Pro— 510(k) K250045

Name: FDA 510(k) clearance K250045
Creator: U.S. Food and Drug Administration
Published: 2025-09-24

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K250045 for uWS-Angio Pro, Substantially Equivalent on 2025-09-24. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-01-10
Decision date: 2025-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Shanghai United Imaging Healthcare Co., Ltd.

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K253726 — uAngio AVIVA CX2026-08-21
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K260113 — uMR Astra2026-05-22
K253077 — uOmnispace.MR2026-04-22
K260524 — uMI Panvivo (5 models)2026-04-03

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.