510(k) K091146 ยท MUJ System, Planning, Radiation Therapy Treatment
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
| Applicant | Accuray, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 1, 2009 |
| Received | Apr 20, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2011 | Accuray Inc Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1.
F Terminated |
MUJ | None listed |
| Feb 1, 2011 | Accuray Inc CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5
Medical charged-particle radiation thera Terminated |
MUJ | None listed |
| Jan 10, 2011 | Accuray Inc CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA.
Medical device indicated for tre Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.