RayStation 11.0
FDA 510(k) clearance K211867 · decided 2021-09-08
Clearance details
- K-number
- K211867
- Device name
- RayStation 11.0
- Applicant
- RaySearch Laboratories AB (PUBL)
- Decision
- Substantially Equivalent
- Date received
- 2021-06-16
- Decision date
- 2021-09-08
- Days to decision
- 84 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: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Versio recall (Z-1103-2026) | RAYSEARCH LABORATORIES AB | 2026-01-16 |
| RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 1 recall (Z-2491-2025) | RAYSEARCH LABORATORIES AB | 2025-09-02 |
| Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Ca recall (Z-1189-2025) | RAYSEARCH LABORATORIES AB | 2025-02-19 |
| RayStation 11.0.0.951, 11.0.1.29, 11.0.3.116 & 11.0.4.15. Radiation Therapy Treatment Plan recall (Z-1748-2024) | 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 |