510(k) K140828 ยท LLZ System, Image Processing, Radiological
NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE
| Applicant | Brainreader Aps, Egaa, DK |
| Decision | Substantially Equivalent, Feb 4, 2015 |
| Received | Apr 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140828
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2020 | Brainreader ApS Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures iden Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.