ClearanceBrief
510(k) K251342 ยท QIH Automated Radiological Image Processing Software

EchoPAC Software Only / EchoPAC Plug-in

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics, Waukesha WI, US
DecisionSubstantially Equivalent, Jul 16, 2025
ReceivedApr 30, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K251342

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.