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510(k) Data Aggregation

    K Number
    K242992
    Device Name
    RayCare (2024A SP1)
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2025-04-17

    (203 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RayCare is an oncology information system intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology. For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment course and monitor the treatment course. In the context of radiation therapy, the RayCare image viewer can be used for viewing images, annotating images, performing and saving image registrations as well as image fusion to enable offline image review of patient positioning during treatment delivery. RayCare is not intended for use in diagnostic activities.
    Device Description
    RayCare is an oncology information system intended to provide information which is used to take decisions for diagnosis, treatment management, treatment planning, scheduling, treatment and follow-up of radiation therapy, medical oncology and surgical oncology. For these disciplines, as applicable, RayCare enables the user to define the clinical treatment intent, prescribe treatment, specify the detailed course of treatment delivery, manage the treatment course and monitor the treatment course. In the context of radiation therapy, the RayCare image viewer can be used for viewing images, annotating images, performing and saving image registrations as well as image fusion to enable offline image review of patient positioning during treatment delivery. As an oncology information system, RayCare supports healthcare professionals in managing cancer care treatments. The system provides functionalities as described briefly in the sections below. These functionalities are not provided separately in different applications and have a joint purpose for the treatment of the patient. RayCare is a software-as a Medical Device with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic.
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    K Number
    K240398
    Device Name
    RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2025-04-04

    (420 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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. RayStation consists of multiple applications: - The main RayStation application is used for treatment planning. - The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems. The devices to be marketed, RayStation/RayPlan 2024A SP3, 2024A and 2023B, contain modified features compared to last cleared version RayStation 12A including: - Improved sliding window VMAT (Volumetric Modulated Arc Therapy) sequencing - Higher dose grid resolution for proton PBS (Pencil Beam Scanning) - Automated field in field planning - LET optimization (Linear Energy Transfer) These applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data. As a treatment planning system, RayStation aims to be an extensive software toolbox for generating and evaluating various types of radiotherapy treatment plans. RayStation supports a wide variety of radiotherapy treatment techniques and features an extensive range of tools for manual or semi-automatic treatment planning. The RayStation application is divided in modules, which are activated through licensing. A simplified license configuration of RayStation is marketed as RayPlan.
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    K Number
    K222312
    Device Name
    RayStation 12A
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2023-03-29

    (240 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. The device lets the user import patient images and data, identify treatment targets and organs at risk, create an optimal treatment plan taking into account patient anatomy, prescribe treatment dose and organ at risk sensitivity, review and approve the plan and then administer the treatment. A scientific basis for the device is the implementation of peer reviewed algorithms of plan parameter optimization and photon and particle dose calculation. RayStation consists of multiple applications: - The main RayStation application is used for treatment planning. - The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems. - The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments. These applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data. The RayStation application is divided in modules, which are activated through licensing. A simplified license configuration of RayStation is marketed as RayPlan has a limited set of modules, indicated in the following table.
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    K Number
    K220141
    Device Name
    RayStation 11B
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2022-04-15

    (87 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines. RayStation consists of multiple applications: - . The main RayStation application is used for treatment planning. - . The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems. - The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments. The device to be marketed, RayStation 11B, contains modified features compared to RayStation 11.0 as indicated below: A simplified license configuration of RayStation is marketed as RayPlan. RayPlan has a limited set of purchasable licenses and some modules will not be accessible. RayPlan is marketed as RayPlan 11B. EQD2 dose computation (new) - From photon and/or braction doses, it is possible to compute, deform and accumulate the two Gray equivalent (EQD2) dose. The computation of the EQD2 dose uses the biological linear quadratic model, which is also the basis for the already released biological optimization and evaluation functionality. Generation of synthetic CT from CBCT (new) - Two new methods (algorithms) for synthetic CT generation will be included. The synthetic CT images are created by combining information in the CBCT image and a CT image for the specific patient to allow for dose computation using the HU values in the image, as for regular CT images. In RayStation 11.0 it is possible to compute dose on CBCT images for photons using bulk density assignments. The added functionality will improve the photon dose calculation accuracy on CBCT images. Handling of LET and other RBE components (new) - This functionality enables possibility to compute and evaluate the dose weighted LET (Linear Energy Transfer) for proton and light ion plans. LET is an additional dosimetric measure that can be used to assess the radiobiological effect of the proton and light ion radiation. Radiobiological equivalent (RBE) dose is a derived quantity with dependence on both the physical dose and the LET. In RayStation 11.0, it is possible to compute and evaluate RBE doses.
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    K Number
    K211867
    Device Name
    RayStation 11.0
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2021-09-08

    (84 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines. RayStation consists of multiple applications: - . The main RayStation application is used for treatment planning. - . The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems. - . The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments. The device to be marketed, RayStation 11.0, marketing name "RayStation 11A", contains modified features compared to version 10.1. The main change is planning for the CyberKnife linear accelerator treatment unit. The device to be marketed supports planning and dose calculation for M6/S7 CyberKnife treatment machines. Older CyberKnife versions are not supported. The CyberKnife has one delivery technique, and different node sets. The node set defines the possible robot positions for different collimations (cones or MLC) and patient geometry (head or body). All node sets available for patient treatments are included in the validation.
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    K Number
    K210645
    Device Name
    RayStation 10.1
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2021-06-29

    (118 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. It has a modern user interface and is equipped with fast and accurate dose and optimization engines. RayStation consists of multiple applications: - The main RayStation application is used for treatment planning. - . The RayPhysics application is used for commissioning of treatment machines to make them available for treatment planning and used for commissioning of imaging systems. - . The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments. - o The RayCommand application is used for treatment session management including treatment preparation and sending instructions to the treatment delivery devices.
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    K Number
    K200569
    Device Name
    RayStation
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2020-09-24

    (204 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
    Device Description
    RayStation 9.1/RayStation 9.2 are radiation therapy treatment planning systems, i.e. a software program for planning and analysis of radiation therapy. The functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation, 4D data compatibility and treatment console interfacing, as well as unique features such as machine learning planning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.
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    K Number
    K200487
    Device Name
    RayCare 3.1
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2020-06-10

    (104 days)

    Product Code
    MUJ, REG
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RayCare is an oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. RayCare may be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology. RayCare is not intended for use in diagnostic activities.
    Device Description
    RayCare is an oncology information system that supports healthcare professionals in managing cancer care. The system is structured in functionality modules that are listed below. RayCare is a software-only system with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic. - Patient clinical data - Care administration - Clinical notes and documents - Workflow and task management - Charge capture - Scheduling and calendar functions - PACS - Image viewer - Simulation and imaging - System administration - Authentication, authorization and audit logging - Hospital system integrations
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    K Number
    K191384
    Device Name
    RayCare 2.3
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2019-07-08

    (46 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RayCare is an oncology information system used to support workflows, scheduling and clinical information management for oncology care and follow-up. RayCare may be used in the transfer, storage, conversion and display of patient data in all areas of cancer care including radiation therapy, medical oncology and surgical oncology. RayCare is not intended for use in diagnostic activities.
    Device Description
    RayCare is an oncology information system that supports healthcare professionals in managing cancer care. The system is structured in functionality modules that are listed below. RayCare is a software-only system with a client part that allows the user to interact with the system and a server part that performs the necessary processing and storage functions. Selected aspects of RayCare are configurable, such as adapting workflow templates to the specific needs of the clinic. - Patient clinical data - Care administration - Clinical notes and documents - Workflow and task management - Charge capture - Scheduling and calendar functions - PACS - Image viewer - Simulation and imaging - System administration - Authentication, authorization and audit logging - Hospital system integrations
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    K Number
    K190387
    Device Name
    RayStation
    Manufacturer
    RaySearch Laboratories AB (publ)
    Date Cleared
    2019-06-19

    (120 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RaySearch Laboratories AB (publ)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
    Device Description
    RayStation 8.1 is a radiation therapy treatment planning system, i.e. a software program for planning, management and analysis of radiation therapy treatment. The functionality includes fusion capabilities (CT, PET and MRI), contouring, collapsed cone convolution dose computation, 4D data compatibility and treatment console interfacing, as well as unique features such as machine learning and segmentation, multi-criteria optimization, dose tracking, treatment adaptation and deformable registration, all available in one platform.
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