RayStation 11B
FDA 510(k) clearance K220141 · decided 2022-04-15
Clearance details
- K-number
- K220141
- Device name
- RayStation 11B
- Applicant
- RaySearch Laboratories AB (PUBL)
- Decision
- Substantially Equivalent
- Date received
- 2022-01-18
- Decision date
- 2022-04-15
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Stockholm, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Softwar recall (Z-1104-2026) | RAYSEARCH LABORATORIES AB | 2026-01-16 |
| RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 1 recall (Z-2492-2025) | RAYSEARCH LABORATORIES AB | 2025-09-02 |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Ca recall (Z-1190-2025) | RAYSEARCH LABORATORIES AB | 2025-02-19 |
| RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Tr recall (Z-1749-2024) | RAYSEARCH LABORATORIES AB | 2024-05-01 |
| RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 1 recall (Z-1482-2024) | RAYSEARCH LABORATORIES AB | 2024-04-05 |