510(k) K151159 ยท IWB System, Radiation Therapy, Radionuclide
Leksell Gamma Knife Perfexion
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Oct 29, 2015 |
| Received | May 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151159
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2016 | Elekta, Inc. Radionuclide Radiation Therapy System
Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.