ClearanceBrief
510(k) K253969 ยท QIH Automated Radiological Image Processing Software

ADAS 3D

ApplicantAdas3D Medical S.L., Barcelona, ES
DecisionSubstantially Equivalent, Jun 29, 2026
ReceivedDec 11, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253969

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.