510(k) K150873 ยท IYE Accelerator, Linear, Medical
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
| Applicant | Accuray Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 1, 2015 |
| Received | Apr 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150873
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2018 | Accuray Incorporated CyberKnife M6, Part Number 054000-004
The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and con Terminated |
IYE | None listed |
| Apr 10, 2018 | Accuray Incorporated CyberKnife M6, Part Numbers:
a) 0660000: CyberKnife Treatment Delivery System
b) 053101-010: CyberKnife M6 FI Treatment Delivery System
c) 053201-010: CyberKnife M6 FM Treatment Delivery System
d) 0 Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.