510(k) K921116 ยท IZL System, X-Ray, Mobile
PX-100 PORTABLE X-RAY GENERATOR
| Applicant | Acoma Medical Imaging, Inc., Wheeling IL, US |
| Decision | Substantially Equivalent, Oct 5, 1992 |
| Received | Mar 9, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921116
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.