510(k) K101398 ยท LLZ System, Image Processing, Radiological
STEREOS WORKSTATION
| Applicant | Biospace Med, Washington DC, US |
| Decision | Substantially Equivalent, Feb 4, 2011 |
| Received | May 18, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101398
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | Eos Imaging Software versions
Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2.
sterEOS software versions: 1.2.3.3788, 1.2.4.428 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.