ClearanceBrief
510(k) K252328 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics, Wauwatosa WI, US
DecisionSubstantially Equivalent, Nov 24, 2025
ReceivedJul 25, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252328

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.