510(k) K092083 ยท IWB System, Radiation Therapy, Radionuclide
EXTEND FRAME SYSTEM, MODEL 1009633
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Sep 22, 2009 |
| Received | Jul 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092083
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2010 | Elekta, Inc. Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden. Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.