510(k) K120233 ยท IYE Accelerator, Linear, Medical
SYNCHRONY RESPIRATORY TRACKING SYSTEM
| Applicant | Accuray Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 9, 2012 |
| Received | Jan 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120233
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2016 | Accuray Incorporated CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package.
Product Usage:
The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereo Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.