510(k) K063512 ยท IWB System, Radiation Therapy, Radionuclide
LEKSELL GAMMA KNIFE PERFEXION
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Mar 5, 2007 |
| Received | Nov 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063512
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2010 | Elekta, Inc. Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092.
Teletherapy device intended for stereotactic irradiation of head structu Terminated |
IWB | None listed |
| Apr 5, 2010 | Elekta, Inc. Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.
Indicated for use in the stereotactic irradiation of intracranial structures. Terminated |
IWB | None listed |
| Apr 5, 2010 | Elekta, Inc. Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.
Intended for stereotactic irradiation of head structures ranging from very sm Terminated |
IWB | None listed |
| Mar 17, 2010 | Elekta, Inc. Leksell Gamma Knife Perfexion, Article #715000.
Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centim Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.