510(k) K192482 ยท IYE Accelerator, Linear, Medical
Elekta Unity
| Applicant | Elekta Limited, Crawley, GB |
| Decision | Substantially Equivalent, Dec 5, 2019 |
| Received | Sep 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192482
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2020 | Elekta Limited Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571 Terminated |
IYE | None listed |
| Jun 5, 2020 | Elekta, Inc. Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign dis Terminated |
IYE | None listed |
| Dec 18, 2019 | Elekta, Inc. Elekta Unity, Image-Guided Radiation Therapy System Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.