RayStation
FDA 510(k) clearance K200569 · decided 2020-09-24
Clearance details
- K-number
- K200569
- Device name
- RayStation
- Applicant
- RaySearch Laboratories AB (PUBL)
- Decision
- Substantially Equivalent
- Date received
- 2020-03-04
- Decision date
- 2020-09-24
- Days to decision
- 204 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 with the following product descriptions: 1. RayStation 9B, Software Version: 9. recall (Z-2489-2025) | RAYSEARCH LABORATORIES AB | 2025-09-02 |
| Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Ca recall (Z-1187-2025) | RAYSEARCH LABORATORIES AB | 2025-02-19 |
| RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System. recall (Z-1745-2024) | RAYSEARCH LABORATORIES AB | 2024-05-01 |
| RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. Radiation Therapy Treatment Planning System recall (Z-1746-2024) | 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 |
| Radiation therapy software, RayStation standalone software treatment planning system. Mode recall (Z-2039-2023) | RaySearch America Inc | 2023-06-29 |