510(k) K061941 ยท IWB System, Radiation Therapy, Radionuclide
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Aug 21, 2006 |
| Received | Jul 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061941
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.