ClearanceBrief
510(k) K250650 ยท JAK System, X-Ray, Tomography, Computed

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

ApplicantArineta , Ltd., Caesarea, IL
DecisionSubstantially Equivalent, Apr 15, 2025
ReceivedMar 4, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250650

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.