510(k) K223229 · IYE Accelerator, Linear, Medical
MOSAIQ® OIS (Oncology Information System)
| Applicant | Elekta Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Feb 23, 2023 |
| Received | Oct 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2026 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | None listed |
| Jan 13, 2026 | Elekta, Inc. MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO) Open, Classified |
IYE | None listed |
| Nov 14, 2025 | ELEKTA SOLUTIONS AB MOSAIQ Oncology Information System
Software Builds
3.1.3, 3.2.1, 3.2.2 & 3.2.3.0
Software Version and UDI Codes:
3.1.3.0 (01)07340201500026(10)3.1.3.0
3.1.3.1 (01)07340201500026(10)3.1.3.1
3.1.3.2 (0 Open, Classified |
IYE | None listed |
| Feb 12, 2025 | Elekta, Inc. MOSAIQ Oncology Information System Open, Classified |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.