ClearanceBrief
510(k) K253502 ยท QIH Automated Radiological Image Processing Software

Critical Care Suite with Enteric Tube Positioning AI Algorithm

ApplicantGe Medical Systems, LLC, Waukesha WI, US
DecisionSubstantially Equivalent, Apr 14, 2026
ReceivedOct 30, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K253502

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.