510(k) K231570 ยท LLZ System, Image Processing, Radiological
StrokeViewer Perfusion
| Applicant | Nico-Lab B.V., Amsterdam, NL |
| Decision | Substantially Equivalent, Dec 14, 2023 |
| Received | May 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231570
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.