510(k) K091999 ยท IYE Accelerator, Linear, Medical
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
| Applicant | Accuray, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 18, 2009 |
| Received | Jul 2, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091999
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2012 | Accuray Incorporated CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation.
Accuray In Terminated |
IYE | None listed |
| Jan 11, 2012 | Accuray Incorporated CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option.
The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurgery and precision radi Terminated |
IYE | None listed |
| Dec 16, 2010 | Accuray Inc CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA.
Indicated for treatment planning and image-guided stereotactic Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.