510(k) K192405 ยท IYE Accelerator, Linear, Medical
Image Guidance System for Radiotherapy
| Applicant | Jiangsu Rayer Medical Technology Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, May 1, 2020 |
| Received | Sep 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192405
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.