510(k) K253058 ยท IZL System, X-Ray, Mobile
Portable DR Imaging System
| Applicant | Shantou Institute of Ultrasonic Instruments Co., Ltd., Shantou, CN |
| Decision | Substantially Equivalent, Jun 18, 2026 |
| Received | Sep 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253058
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.