510(k) K103093 ยท MUJ System, Planning, Radiation Therapy Treatment
LEKSELL GAMMAPLAN
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Dec 21, 2010 |
| Received | Oct 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103093
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2015 | Elekta, Inc. Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment. Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.