510(k) K173791 ยท IWB System, Radiation Therapy, Radionuclide
Leksell GammaPlan
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Feb 9, 2018 |
| Received | Dec 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2026 | Elekta, Inc. Brand Name: Leksell GammaPlan
Product Name: Radionuclide RT Treatment planning system
Software Version: 11,3, 11.4
Product Description: Leksell GammaPlan is a computer-based system designed for Leksel Open, Classified |
MUJ | None listed |
| Jun 27, 2018 | Elekta Instrument AB Leksell GammaPlan 11.1
Product Usage:
Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning. Open, Classified |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.