ClearanceBrief
510(k) K211711 ยท JAK System, X-Ray, Tomography, Computed

OmniTom Elite

ApplicantNeurologica Corporation, A Subsidiary of Samsung Electronics, Danvers MA, US
DecisionSubstantially Equivalent, Feb 25, 2022
ReceivedJun 3, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K211711

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.