510(k) K092102 ยท LLZ System, Image Processing, Radiological
NORDICBRAINEX SOFTWARE, VERSION 1.0
| Applicant | Nordicimaginglab AS, Bergen, Hordaland, NO |
| Decision | Substantially Equivalent, Aug 25, 2009 |
| Received | Jul 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092102
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2012 | NordicNeuroLab AS nordicBrainEX
Product Usage:
nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software ru Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.