510(k) K212114 ยท IYE Accelerator, Linear, Medical
Elekta Unity
| Applicant | Elekta Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Oct 1, 2021 |
| Received | Jul 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2023 | Elekta, Inc. Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.