MOSAIQ® OIS (Oncology Information System)— 510(k) K223229
Substantially EquivalentElekta Solutions AB
FDA 510(k) clearance K223229 for MOSAIQ® OIS (Oncology Information System), Substantially Equivalent on 2023-02-23. Applicant: Elekta Solutions AB. Device class: 2.
Clearance details
- Applicant
- Elekta Solutions AB
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
Recent devices under product code IYE
view allMore clearances from Elekta Solutions AB
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K223229
K-number listed on FDA's recall record- Z-2406-2026 — MOSAIQ Oncology Information System
- Z-1078-2026 — MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
- Z-0503-2026 — 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 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0 MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
- Z-1162-2025 — MOSAIQ Oncology Information System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223229.
Data sourced from openFDA. This site is unofficial and independent of the FDA.