510(k) K051673 ยท LLZ System, Image Processing, Radiological
XELERIS 2 PROCESSING AND REVIEW WORKSTATION
| Applicant | GE Medical Systems, Waukesha WI, US |
| Decision | Substantially Equivalent, Jul 18, 2005 |
| Received | Jun 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2013 | GE Healthcare, LLC GE Healthcare, Xeleris 2 Processing & Review Workstation.
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including Terminated |
LLZ | None listed |
| 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 |
| Dec 3, 2010 | GE Healthcare, LLC XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, incl Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.