ClearanceBrief
510(k) K253535 ยท QIH Automated Radiological Image Processing Software

Ligence Heart

ApplicantLigence Uab, Kaunas, LT
DecisionSubstantially Equivalent, Feb 27, 2026
ReceivedNov 13, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253535

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.