ClearanceBrief
510(k) K243853 ยท QIH Automated Radiological Image Processing Software

Clarius Prostate AI

ApplicantClarius Mobile Health Corp., Vancouver, CA
DecisionSubstantially Equivalent, Apr 16, 2025
ReceivedDec 16, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243853

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.