510(k) K082441 ยท LLZ System, Image Processing, Radiological
NORDICICE SOFTWARE
| Applicant | Nordicimaginglab AS, Bergen, Hordaland, NO |
| Decision | Substantially Equivalent, Nov 21, 2008 |
| Received | Aug 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2015 | NordicNeuroLab AS nordicICE v 2.3.14
nordicICE 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 standa Terminated |
LLZ | None listed |
| Sep 12, 2014 | NordicNeuroLab AS nordicICE 2.3.14
Image processing software package used by trained professionals, including physicians and medical technicians. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.