510(k) K261125 ยท JAK System, X-Ray, Tomography, Computed
BodyTom 64 (NL4100); OmniTom Elite (NL5000)
| Applicant | Samsung HME America, Inc., dba NeuroLogica Corp., Danvers MA, US |
| Decision | Substantially Equivalent, Sep 22, 2026 |
| Received | Apr 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261125
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.