FDA-cleared K220141

RayStation 11B

RaySearch Laboratories AB (publ)

RayStation 11B is configurable radiation-treatment planning and analysis software for qualified staff, supporting image handling, contouring, multimodality fusion, dose...

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

RayStation 11.0

RaySearch Laboratories AB (publ)

RayStation 11.0 is configurable radiation-treatment planning and analysis software for qualified staff, supporting image handling, contouring, multimodality fusion, dose...

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

RayStation 10.1

RaySearch Laboratories AB (publ)

RayStation 10.1 is configurable radiation-treatment planning software for radiation therapy and medical oncology that supports treatment-plan proposal, review, approval, and...

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 for trained, clinically qualified...

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

RayCare 2.3

RaySearch Laboratories AB (publ)

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,...

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 for trained, clinically qualified radiation therapy staff. It...

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