510(k) K242015 ยท IZL System, X-Ray, Mobile
TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
| Applicant | DRGEM Corporation, Gwangmyeong-Si, KR |
| Decision | Substantially Equivalent, Dec 16, 2024 |
| Received | Jul 10, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242015
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.