ClearanceBrief
510(k) K251443 ยท IZL System, X-Ray, Mobile

PROMO

ApplicantDRGEM Corporation, Gwangmyeong-Si, KR
DecisionSubstantially Equivalent, Aug 22, 2025
ReceivedMay 9, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251443

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.