510(k) K153355 ยท LLZ System, Image Processing, Radiological
Xeleris 4.0 Processing and Review Workstation
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Mar 16, 2016 |
| Received | Nov 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153355
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.