510(k) K203172 ยท IYE Accelerator, Linear, Medical
MOSAIQ Oncology Information System
| Applicant | Elekta Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Dec 18, 2020 |
| Received | Oct 26, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2026 | Elekta, Inc. MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.