GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)— 510(k) K232178

Name: FDA 510(k) clearance K232178
Creator: U.S. Food and Drug Administration
Published: 2023-09-19

Substantially Equivalent

DRGEM Corporation

FDA 510(k) clearance K232178 for GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series), Substantially Equivalent on 2023-09-19. Applicant: DRGEM Corporation. Device class: 2.

Clearance details

Applicant: DRGEM Corporation
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2023-07-24
Decision date: 2023-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwang-Myeong-Si, KR

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.