510(k) K250911 ยท IYE Accelerator, Linear, Medical
MOSkin Radiation Measurement System
| Applicant | Electrogenics Labs, Ltd., North Sydney, AU |
| Decision | Substantially Equivalent, Oct 17, 2025 |
| Received | Mar 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250911
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.