510(k) K052325 ยท MUJ System, Planning, Radiation Therapy Treatment
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
| Applicant | Accuray Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 14, 2005 |
| Received | Aug 25, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052325
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2007 | Accuray Inc Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089. Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.