510(k) K182076 ยท IYE Accelerator, Linear, Medical
Elekta Unity
| Applicant | Elekta Limited, Crawley, GB |
| Decision | Substantially Equivalent, Dec 4, 2018 |
| Received | Aug 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182076
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2019 | Elekta, Inc. Elekta Unity, Image-Guided Radiation Therapy System
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and Terminated |
IYE | None listed |
| May 8, 2019 | Elekta Limited Elekta Unity systems
Product Usage:
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases Terminated |
IYE | None listed |
| Mar 12, 2019 | Elekta Limited Elekta Unity, Image-Guided Radiation Therapy System
Product Usage:
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of Terminated |
IYE | None listed |
| Jan 4, 2019 | Elekta Limited Elekta Unity Completed |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.