510(k) K253450 ยท JAK System, X-Ray, Tomography, Computed
BodyTom Elite (NL4000)
| Applicant | NeuroLogica Corp., a Samsung Company, Danvers MA, US |
| Decision | Substantially Equivalent, Jul 28, 2026 |
| Received | Oct 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253450
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.