510(k) K133910 ยท LLZ System, Image Processing, Radiological
NORDICBRAINEX
| Applicant | Nordicneurolab, Bergen, NO |
| Decision | Substantially Equivalent, Apr 4, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2022 | NordicNeuroLab AS nordicBrainEX, software versions 2.21 through 2.3.10 Terminated |
LLZ | None listed |
| Sep 17, 2014 | NordicNeuroLab AS nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.