510(k) K171837 ยท IYE Accelerator, Linear, Medical
TomoTherapy Treatment Delivery System with iDMS
| Applicant | Accuray Incorporated, Madison WI, US |
| Decision | Substantially Equivalent, Jul 25, 2017 |
| Received | Jun 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2020 | Accuray Incorporated TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic rad Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.