ClearanceBrief
510(k) K250524 ยท ITX Transducer, Ultrasonic, Diagnostic

Mendaera Guidance System

ApplicantMendaera, Inc., San Mateo CA, US
DecisionSubstantially Equivalent, Jul 2, 2025
ReceivedFeb 21, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250524

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.