510(k) K111304 ยท IXL Device, Spot-Film
OPTIMA XR120
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Jul 19, 2011 |
| Received | May 9, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111304
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.