510(k) K010304 ยท IZL System, X-Ray, Mobile
MXR-2000 MOBILE X-RAY UNIT
| Applicant | Irom Imaging, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Feb 12, 2001 |
| Received | Feb 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010304
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.