510(k) K984328 ยท IWB System, Radiation Therapy, Radionuclide
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
| Applicant | Elekta Instrument AB, San Diego CA, US |
| Decision | Substantially Equivalent, May 21, 1999 |
| Received | Dec 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2011 | Elekta, Inc. Elekta Leksell Gamma Knife C 1.2, 4 and 4C
Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures. Terminated |
IWB | None listed |
| Apr 29, 2010 | Elekta, Inc. Leksell Gamma Knife C Terminated |
IWB | None listed |
| Apr 22, 2010 | Elekta, Inc. Leksell Gamma Knife C Terminated |
IWB | None listed |
| Apr 13, 2010 | Elekta, Inc. Leksell Gamma Knife.
Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.