510(k) K183292 ยท IZL System, X-Ray, Mobile
Topaz Mobile DR System
| Applicant | DRGEM Corporation, Gwangmyeong-Si, KR |
| Decision | Substantially Equivalent, May 15, 2019 |
| Received | Nov 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183292
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.