510(k) K133565 ยท IWB System, Radiation Therapy, Radionuclide
LEKSELL GAMMA KNIFE PERFEXION
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, May 9, 2014 |
| Received | Nov 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133565
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.