510(k) K102650 ยท IYE Accelerator, Linear, Medical
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
| Applicant | Accuray Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 17, 2010 |
| Received | Sep 14, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 11, 2011 | Accuray Incorporated CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch).
Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 0281 Terminated |
IYE | None listed |
| Oct 11, 2011 | Accuray Incorporated CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186.
Product is manufacture Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.