510(k) K042146 ยท JAI Couch, Radiation Therapy, Powered
ROBOCOUCH PATIENT SUPPORT SYSTEM
| Applicant | Accuray Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 17, 2004 |
| Received | Aug 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042146
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2013 | Accuray Incorporated RoboCouch Patient Positioning System
Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when Terminated |
JAI | 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 |
| Jan 14, 2009 | Accuray Inc RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA
The CyberKnife is indicated for treatment Terminated |
JAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.