510(k) K122137 ยท IYE Accelerator, Linear, Medical
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
| Applicant | Accuray Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 26, 2012 |
| Received | Jul 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2016 | Accuray Incorporated CyberKnife Robotic Radiosurgery System using software version 10.6;
Catalog/Part Number: 54000
UDI: M658053301 0
Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment plann Terminated |
IYE | None listed |
| Nov 14, 2014 | Accuray Incorporated CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator.
The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and p Terminated |
IYE | None listed |
| Jan 27, 2014 | Accuray Incorporated Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA.
Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy. Terminated |
IYE | None listed |
| Apr 16, 2013 | Accuray Incorporated Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberK Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.