510(k) K183034 ยท IYE Accelerator, Linear, Medical
MOSAIQ Oncology Information System
| Applicant | Elekta, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 4, 2018 |
| Received | Nov 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2021 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | None listed |
| Apr 20, 2021 | Elekta, Inc. Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.