ClearanceBrief
510(k) K251837 ยท QIH Automated Radiological Image Processing Software

Salix Coronary Plaque (V1.0.0)

ApplicantArtrya Limited, Perth, AU
DecisionSubstantially Equivalent, Aug 20, 2025
ReceivedJun 16, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251837

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.