ClearanceBrief
510(k) K251322 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

Venue; Venue Go; Venue Fit; Venue Sprint

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US
DecisionSubstantially Equivalent, Jul 25, 2025
ReceivedApr 29, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251322

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.