510(k) K171183 ยท JAK System, X-Ray, Tomography, Computed
OmniTom
| Applicant | Neurologica Corporation, Danvers MA, US |
| Decision | Substantially Equivalent, Aug 18, 2017 |
| Received | Apr 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171183
| 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 |
| Jul 15, 2020 | NeuroLogica Corporation OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.