510(k) K082122 ยท IYE Accelerator, Linear, Medical
MLCI2
| Applicant | Elekta , Ltd., West Sussex, GB |
| Decision | Substantially Equivalent, Aug 29, 2008 |
| Received | Jul 28, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2012 | Elekta, Inc. MLCi/MCLi2.
Radiation therapy. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.