RayStation— 510(k) K200569

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

2020-03-04

Decision date

2020-09-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stockholm, SE

• K260750 — Virtual Cone (1.0)2026-07-08
• K253050 — RadOncAI2026-06-18
• 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-2489-2025 — RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.Class II·Ongoing·RAYSEARCH LABORATORIES AB·20250808
• Z-1187-2025 — Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2Class II·Ongoing·RAYSEARCH LABORATORIES AB·20250116
• Z-1745-2024 — RayStation 9.1.0.933 and 9.2.0.483. Radiation Therapy Treatment Planning System.Class II·Ongoing·RAYSEARCH LABORATORIES AB·20240328
• Z-1746-2024 — RayStation 10.0.0.1154, 10.0.1.52 & 10.0.2.10. 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-1403-2022 — RayStation 9B SP1. For radiation treatment planning.Class II·Terminated·RAYSEARCH LABORATORIES AB·20220601
• Z-2138-2021 — RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.113) 07350002010174; RayStation 9.1 (9.1.0.933) 07350002010266; RayStation 9.1 Service Pack 1 (9.2.0.483) 07350002010297; RayStation 10.0 (10.0.0.1154) 07350002010303; RayStation 10.0 Service Pack 1 (10.0.1.52) 07350002010365; RayStation 10.1 (10.1.0.613) 07350002010310; RayStation 11.0 (11.0.0.951) 07350002010389;Class II·Terminated·RAYSEARCH LABORATORIES AB·20210608
• Z-1838-2021 — RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 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 or 10.1.0.613 .Class II·Terminated·RAYSEARCH LABORATORIES AB·20210421
• Z-1598-2021 — RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packsClass II·Terminated·RAYSEARCH LABORATORIES AB·20210407
• Z-1427-2021 — RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)Class II·Ongoing·RAYSEARCH LABORATORIES AB·20210325
• Z-1597-2021 — RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning systemClass II·Terminated·RAYSEARCH LABORATORIES AB·20210222
• Z-2039-2023 — Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1.Class II·Terminated·RaySearch America Inc·20210122
• Z-0589-2021 — RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0)Class II·Terminated·RAYSEARCH LABORATORIES AB·20201111
• Z-0478-2021 — RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.Class II·Terminated·RAYSEARCH LABORATORIES AB·20201008

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200569.