510(k) K113034 ยท IZI System, X-Ray, Angiographic
GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM
| Applicant | GE Healthcare, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 13, 2011 |
| Received | Oct 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113034
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.