510(k) K151666 ยท MUJ System, Planning, Radiation Therapy Treatment
Leksell GammaPlan
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Sep 3, 2015 |
| Received | Jun 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151666
| 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: 11.1
Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamm Open, Classified |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.