uDR 592h, uDR 596i— 510(k) K192293

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K192293 for uDR 592h, uDR 596i, Substantially Equivalent on 2019-09-12. Applicant: Shanghai United Imaging Healthcare Co., Ltd..

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2019-08-23
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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.