510(k) K170788 ยท IYE Accelerator, Linear, Medical
CyberKnife Treatment Delivery System
| Applicant | Accuray Incorportaed, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Apr 11, 2017 |
| Received | Mar 16, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Accuray Incorporated Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator Open, Classified |
IYE | None listed |
| Jul 1, 2026 | Accuray Incorporated Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator Open, Classified |
IYE | None listed |
| Jan 27, 2025 | Accuray Incorporated CyberKnife Treatment Delivery System, REF 0660000
The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for i Completed |
IYE | None listed |
| Feb 26, 2021 | Accuray Incorporated CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radia Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.