510(k) K011024 ยท IYE Accelerator, Linear, Medical
CYBERKNIFE SYSTEM
| Applicant | Accuray, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 10, 2001 |
| Received | Apr 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011024
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2016 | Accuray Incorporated CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI.
Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and Terminated |
IYE | None listed |
| Jul 13, 2010 | Oridion Medical 1987 Ltd. Microstream O2/CO2 NASAL FILTERLINE ADULT LONG O2 CONN 100UN
Part Number: 010343
010341
Part Number: 10341 Terminated |
CCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.