510(k) K160440 ยท IWB System, Radiation Therapy, Radionuclide
Leksell Gamma Knife Icon
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Apr 20, 2016 |
| Received | Feb 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2017 | Elekta, Inc. Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metasta Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.