510(k) K123306 ยท LLZ System, Image Processing, Radiological
NORDIC TUMOREX
| Applicant | Nordicneurolab, Bergen, Hordaland, NO |
| Decision | Substantially Equivalent, May 20, 2013 |
| Received | Oct 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2014 | NordicNeuroLab AS nordicTumorEx 1.0
nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a st Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.