ClearanceBrief
510(k) K232178 ยท KPR System, X-Ray, Stationary

GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)

ApplicantDRGEM Corporation, Gwang-Myeong-Si, KR
DecisionSubstantially Equivalent, Sep 19, 2023
ReceivedJul 24, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K232178

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.