DeviceClearance

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

Substantially Equivalent

DRGEM Corporation

Clearance details

Applicant
DRGEM Corporation
Product code
Code KPR
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gwang-Myeong-Si, KR
Download summary PDFView on FDA.gov ↗

Adverse events under product code KPR

product code KPR
Other
6
Total
6

Source: openFDA MAUDE database, through . 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.