RayStation 10.1— 510(k) K210645

Clearance details

Applicant

RaySearch Laboratories AB (PUBL)

Product code

Code MUJ

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2021-03-03

Decision date

2021-06-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stockholm, SE

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• K260207 — Multimodality Simulation Workspace (MM Sim) (v1.0.0)2026-05-27
• K252784 — eXaSkin Plus2026-05-22
• K253078 — ART.1-US2026-05-14

• K252109 — RayStation (2024A SP3)2025-12-22
• K242992 — RayCare (2024A SP1)2025-04-17
• K240398 — RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP32025-04-04
• K222312 — RayStation 12A2023-03-29
• K220141 — RayStation 11B2022-04-15

• Z-1102-2026 — RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning SystemClass II·Ongoing·RAYSEARCH LABORATORIES AB·20251128
• Z-2490-2025 — RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.Class II·Ongoing·RAYSEARCH LABORATORIES AB·20250808
• Z-1188-2025 — Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1Class II·Ongoing·RAYSEARCH LABORATORIES AB·20250116
• Z-1747-2024 — RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.Class II·Ongoing·RAYSEARCH LABORATORIES AB·20240328
• Z-1482-2024 — RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.Class II·Ongoing·RAYSEARCH LABORATORIES AB·20240223
• Z-0848-2022 — TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.Class II·Terminated·RAYSEARCH LABORATORIES AB·20210909

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K210645.