ClearanceBrief
510(k) K260497 ยท QIH Automated Radiological Image Processing Software

DEEPVESSEL Plaque

ApplicantKeya Medical Technology Co., Ltd., Beijing, CN
DecisionSubstantially Equivalent, Jun 4, 2026
ReceivedFeb 13, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K260497

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.