510(k) K093982 ยท LLZ System, Image Processing, Radiological
XELERIS 3 PROCESSING AND REVIEW WORKSTATION
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Jan 8, 2010 |
| Received | Dec 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093982
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2011 | GE Healthcare, LLC Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, includ Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.