ClearanceBrief
510(k) K253614 ยท QIH Automated Radiological Image Processing Software

EchoNavigator R5.0

ApplicantPhilips Medical Systems Nederland B.V., Best, NL
DecisionSubstantially Equivalent, Mar 17, 2026
ReceivedNov 18, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253614

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.