ClearanceBrief
510(k) K242314 ยท LLZ System, Image Processing, Radiological

Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

ApplicantAugment Intelligent Medical System (China) Co., Ltd., Nanjing, CN
DecisionSubstantially Equivalent, Sep 11, 2025
ReceivedAug 5, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K242314

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.