510(k) K250686 ยท LLZ System, Image Processing, Radiological
GyriCalc (Version 1.0.0)
| Applicant | Neurospectrum Insights Corp., Bedminster NJ, US |
| Decision | Substantially Equivalent, Jul 22, 2025 |
| Received | Mar 6, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250686
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.