510(k) K252000— uDR Arria & uDR Aris

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2025-06-27
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.