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FDA-cleared K240398

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

RaySearch Laboratories AB (PUBL)

Authorized purpose: RayStation and RayPlan releases covered by K240398 are configurable radiotherapy and medical-oncology software that proposes or supports treatment plans from user inputs, with authorized users required to review and approve plans before treatment.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-04-04
FDA-cleared K222312

RayStation 12A

RaySearch Laboratories AB (publ)

Authorized purpose: RayStation 12A is configurable software for radiation therapy and medical oncology that proposes treatment plans from user input. Authorized users may use reviewed and approved plans to support treatment administration; the system includes image handling, contouring, treatment planning and optimization, dose calculation and evaluation, machine commissioning, treatment interfaces, and machine-learning segmentation or planning functions.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-03-29
FDA-cleared K220141

RayStation 11B

RaySearch Laboratories AB (publ)

Authorized purpose: RayStation 11B is configurable radiation-treatment planning and analysis software for qualified staff, supporting image handling, contouring, multimodality fusion, dose calculation, optimization, plan evaluation, and export of approved treatment plans.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-04-15
FDA-cleared K211867

RayStation 11.0

RaySearch Laboratories AB (publ)

Authorized purpose: RayStation 11.0 is configurable radiation-treatment planning and analysis software for qualified staff, supporting image handling, contouring, multimodality fusion, dose calculation, optimization, evaluation, and export of approved plans.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-09-08
FDA-cleared K210645

RayStation 10.1

RaySearch Laboratories AB (publ)

Authorized purpose: RayStation 10.1 is configurable treatment-planning software for radiation therapy and medical oncology that receives clinician-selected patient and treatment inputs, proposes treatment plans, and supports qualified review, approval, and export for compatible treatment-delivery workflows.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-06-29
FDA-cleared K200569

RayStation

RaySearch Laboratories AB (publ)

RayStation 9.1 and 9.2, marketed as RayStation 9B and 9B SP1, are configurable radiation therapy treatment-planning and analysis software. They support image import and fusion, contouring, dose calculation, optimization, plan evaluation, and export of approved treatment plans, with added dual-energy CT and stereotactic-radiosurgery dose-calculation support, Toshiba beam-intensity calculation, and seated treatments.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-09-24
FDA-cleared K191384

RayCare 2.3

RaySearch Laboratories AB (publ)

Authorized purpose: RayCare is an oncology information system used to support workflows, scheduling, and clinical information management for oncology care and follow-up. It may transfer, store, convert, and display patient data in cancer care including radiation therapy, medical oncology, and surgical oncology. RayCare is not intended for diagnostic activities.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient data across radiation, medical, and surgical oncology care; no diagnostic anatomy
Decision
2019-07-08
FDA-cleared K190387

RayStation

RaySearch Laboratories AB (publ)

RayStation 8.1, marketed as RayStation 8B, is configurable radiation therapy treatment-planning and analysis software. It imports patient images, supports contouring, image fusion, dose calculation, optimization and plan evaluation, and exports approved treatment plans with dose, structure, and image data for treatment.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2019-06-19