GXR-Series Diagnostic X-Ray System— 510(k) K192364

Substantially Equivalent

DRGEM Corporation

FDA 510(k) clearance K192364 for GXR-Series Diagnostic X-Ray System, Substantially Equivalent on 2019-09-26. Applicant: DRGEM Corporation.

Clearance details

Applicant: DRGEM Corporation
Product code: Code KPR
Advisory panel: Radiology
Date received: 2019-08-30
Decision date: 2019-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gwangmyeong-Si, KR

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.