510(k) K132261 ยท IZF System, X-Ray, Tomographic
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 18, 2013 |
| Received | Jul 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2014 | GE Healthcare, LLC GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all a Terminated |
LZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.