510(k) K973441 ยท IWB System, Radiation Therapy, Radionuclide
LEKSELL GAMMAPLAN
| Applicant | Patterson Consulting Group, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 1, 1998 |
| Received | Sep 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2011 | Elekta, Inc. Elekta Leksell Gamma Plan
Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning. Terminated |
IWB | None listed |
| Feb 14, 2011 | Elekta, Inc. Leksell GammaPlan, Model 5.34.
Intended to be used for planning the dosimetry of treatments in stereotactic radiation therapy. Terminated |
IWB | None listed |
| May 14, 2010 | Elekta, Inc. Leksell GammaPlan 8.0 image fusion
Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. the Leksell GammaPlan is intended to be used for planning t Terminated |
IWB | None listed |
| Apr 27, 2010 | Elekta, Inc. Leksell GammaPlan.
Leksell GammaPlan is designed for use with the Leksell Gamma Knife manufactured by Elekta Instrument AB. The Leksell GammaPlan is intended to be used for planning the dosimetry of Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.