510(k) K161146 ยท IYE Accelerator, Linear, Medical
Radixact Treatment Delivery System
| Applicant | Accuray Incorporated, Madison WI, US |
| Decision | Substantially Equivalent, Jun 24, 2016 |
| Received | Apr 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2023 | Accuray Incorporated Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System. Completed |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.