RayStation— 510(k) K190387

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

2019-02-19

Decision date

2019-06-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stockholm, SE

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• 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-2488-2025 — RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System.Class II·Ongoing·RAYSEARCH LABORATORIES AB·20250808
• Z-1186-2025 — Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1Class II·Ongoing·RAYSEARCH LABORATORIES AB·20250116
• Z-1743-2024 — RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System.Class II·Ongoing·RAYSEARCH LABORATORIES AB·20240328
• Z-1744-2024 — RayStation 9.0.0.113 and 9.0.1.142. 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-1281-2023 — Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packsClass II·Ongoing·RAYSEARCH LABORATORIES AB·20230217
• Z-2426-2020 — RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2Class II·Ongoing·RAYSEARCH LABORATORIES AB·20200526
• Z-2339-2020 — RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2340-2020 — RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2341-2020 — RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2342-2020 — RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2343-2020 — RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2344-2020 — RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2345-2020 — RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2346-2020 — RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2347-2020 — RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2348-2020 — RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2349-2020 — RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2350-2020 — RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518
• Z-2351-2020 — RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.Class II·Terminated·RAYSEARCH LABORATORIES AB·20200518

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190387.