510(k) K202526 ยท JAK System, X-Ray, Tomography, Computed
OmniTom Elite
| Applicant | Neurologica Corporation, A Subsidiary of Samsung Electronics, Danvers MA, US |
| Decision | Substantially Equivalent, Dec 23, 2020 |
| Received | Sep 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2023 | NeuroLogica Corporation OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck
Model Number: NL5000 Open, Classified |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.