FS-500DDR Medical Radiographic X-Ray System— 510(k) K152813

Name: FDA 510(k) clearance K152813
Creator: U.S. Food and Drug Administration
Published: 2016-12-02

Substantially Equivalent

Orich Medical Equipment (Tianjin) Co., Ltd.

FDA 510(k) clearance K152813 for FS-500DDR Medical Radiographic X-Ray System, Substantially Equivalent on 2016-12-02. Applicant: Orich Medical Equipment (Tianjin) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Orich Medical Equipment (Tianjin) Co., Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2015-09-28
Decision date: 2016-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin Economic Technological Developme, CN

Download summary PDF View on FDA.gov ↗

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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.