510(k) K120811 ยท IWB System, Radiation Therapy, Radionuclide
LEKSELL GAMMA KNIFE PERFEXION
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, May 24, 2012 |
| Received | Mar 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120811
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2014 | Elekta, Inc. Laksell Gamma Knife Perfexion Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.