ClearanceBrief
510(k) K261042 ยท QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Lung Guidance

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Waukesha WI, US
DecisionSubstantially Equivalent, Oct 2, 2026
ReceivedMar 31, 2026
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K261042

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.