510(k) K072504 ยท IYE Accelerator, Linear, Medical
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
| Applicant | Accuray Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 21, 2007 |
| Received | Sep 6, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072504
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2011 | Accuray Inc CyberKnife System Robotic Radiosurgery System, (Standard Treatment Couch) Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185, Product is manufactured and Terminated |
IYE | None listed |
| Jan 18, 2011 | Accuray Inc CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model Numbers: 026430, 028186, Product is manuf Terminated |
IYE | None listed |
| Jan 11, 2011 | Accuray Inc RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA.
Intended for use in the support Terminated |
JAI | None listed |
| Sep 14, 2009 | Accuray Inc CyberKnife Treatment Delivery System, a subsystem of the CyberKnife Robotic Radiosurgery System, manufactured by Accuray Inc., Sunnyvale, CA.
Indicated for treatment for planning and image-guided ste Terminated |
IYE | None listed |
| Jan 17, 2009 | Accuray Inc Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0.
Product is indicated for t Terminated |
IYE | None listed |
| Sep 17, 2008 | Accuray Inc CyberKnife Robotic Radiosurgery System radiation therapy device with Multiplan treatment Planning Software versions 1.5.2 and higher. Terminated |
IYE | None listed |
| Sep 16, 2008 | Accuray Inc Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device is indi Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.