ClearanceBrief
510(k) K243685 ยท QIH Automated Radiological Image Processing Software

MammoScreen BD

ApplicantTherapixel, Nice, FR
DecisionSubstantially Equivalent, Aug 22, 2025
ReceivedNov 29, 2024
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K243685

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.