ClearanceBrief
510(k) K223909 ยท LLZ System, Image Processing, Radiological

R2GATE Lite TM

ApplicantMegagen Implant Co., Ltd., Deagu, KR
DecisionSubstantially Equivalent, Oct 20, 2023
ReceivedDec 29, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K223909

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.