510(k) K130395 ยท LLZ System, Image Processing, Radiological
STEREOS WORKSTATION
| Applicant | Eos Imaging, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Mar 11, 2013 |
| Received | Feb 15, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 26, 2013 | EOS Imaging steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images
Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and dig Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.