510(k) K200637 ยท IZL System, X-Ray, Mobile
SR-8100 Portable X-ray Unit
| Applicant | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), Shantou, CN |
| Decision | Substantially Equivalent, Jul 9, 2020 |
| Received | Mar 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200637
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.