510(k) K250928 ยท JAK System, X-Ray, Tomography, Computed
OmniTom Elite with PCD
| Applicant | Neurologica Corporation, Danvers MA, US |
| Decision | Substantially Equivalent, Sep 8, 2025 |
| Received | Mar 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250928
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.