510(k) K260085 ยท IZL System, X-Ray, Mobile
RAYMO Mobile X-ray System (Model: RAYMO)
| Applicant | DRGEM Corporation, Gwangmyeong-Si, KR |
| Decision | Substantially Equivalent, May 14, 2026 |
| Received | Jan 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260085
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.