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510(k) Data Aggregation

    K Number
    K242729
    Device Name
    AutoContour (Model RADAC V4)
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2024-12-09

    (90 days)

    Product Code
    QKB, OKB
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
    Device Description
    As with AutoContour Model RADAC V3, the AutoContour Model RADAC V4 device is software that uses DICOM-compliant image data (CT or MR) as input to: (1) automatically contour various structures of interest for radiation therapy treatment planning using machine learning based contouring. The deep-learning based structure models are trained using imaging datasets consisting of anatomical organs of the head and neck, thorax, abdomen and pelvis for adult male and female patients, (2) allow the user to review and modify the resulting contours, and (3) generate DICOM-compliant structure set data the can be imported into a radiation therapy treatment planning system. AutoContour Model RADAC V4 consists of 3 main components: - 1. A .NET client application designed to run on the Windows Operating System allowing the user to load image and structure sets for upload to the cloud-based server for automatic contouring, perform registration with other image sets, as well as review, edit, and export the structure set. - 2. A local "agent" service designed to run on the Windows Operating System that is configured by the user to monitor a network storage location for new CT and MR datasets that are to be automatically contoured. - 3. A cloud-based automatic contouring service that produces initial contours based on image sets sent by the user from the .NET client application.
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    K Number
    K230685
    Device Name
    AutoContour Model RADAC V3
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2023-04-14

    (32 days)

    Product Code
    QKB
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AutoContour is intended to assist radiation treatment planners in contouring structures within medical images in preparation for radiation therapy treatment planning.
    Device Description
    As with AutoContour Model RADAC V2, the AutoContour Model RADAC V3 device is software that uses DICOM-compliant image data (CT or MR) as input to: (1) automatically contour various structures of interest for radiation therapy treatment planning using machine learning based contouring. The deep-learning based structure models are trained using imaging datasets consisting of anatomical organs of the head and neck, thorax, abdomen and pelvis for adult male and female patients, (2) allow the user to review and modify the resulting contours, and (3) generate DICOM-compliant structure set data the can be imported into a radiation therapy treatment planning system. AutoContour Model RADAC V3 consists of 3 main components: - 1. A .NET client application designed to run on the Windows Operating System allowing the user to load image and structure sets for upload to the cloud-based server for automatic contouring, perform registration with other image sets, as well as review, edit, and export the structure set. - 2. A local "agent" service designed to run on the Windows Operating System that is configured by the user to monitor a network storage location for new CT and MR datasets that are to be automatically contoured. - 3. A cloud-based automatic contouring service that produces initial contours based on image sets sent by the user from the .NET client application.
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    K Number
    K220598
    Device Name
    AutoContour Model RADAC V2
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2022-08-24

    (175 days)

    Product Code
    QKB
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AutoContour is intended to assist radiation treatment planners in contouring structures within medical images in preparation for radiation therapy treatment planning.
    Device Description
    As with AutoContour RADAC, the AutoContour RADAC V2 device is software that uses DICOM-compliant image data (CT or MR) as input to (1) automatically contour various structures of interest for radiation therapy treatment planning using machine learning based contouring. The deep-learning based structure models are trained using imaging datasets consisting of anatomical orqans of the head and neck, thorax, abdomen and pelvis for adult male and female patients.(2) allow the user to review and modify the resulting contours, and (3) generate DICOM-compliant structure set data the can be imported into a radiation therapy treatment planning system AutoContour RADAC V2 consists of 3 main components: - 1. A .NET client application designed to run on the Windows Operating System allowing the user to load image and structure sets for upload to the cloud-based server for automatic contouring, perform registration with other image sets, as well as review, edit, and export the structure set. - 2. A local "agent" service designed to run on the Windows Operating System that is configured by the user to monitor a network storage location for new CT and MR datasets that are to be automatically contoured. - 3. A cloud-based automatic contouring service that produces initial contours based on image sets sent by the user from the .NET client application.
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    K Number
    K220583
    Device Name
    ClearCheck Model RADCC V2
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2022-08-23

    (175 days)

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

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearCheck is intended to assist radiation therapy professionals in generating and assessing the quality of radiotherapy treatment plans. ClearCheck is also intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
    Device Description
    The ClearCheck Model RADCC V2 device is software that uses treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming Interfaces to present radiotherapy treatment plans in a user-friendly way for user approval of the treatment plan. The ClearCheck device (Model RADCC V2) is also intended to assist users to identify where collisions between the treatment machine and the patient or support structures may occur in a treatment plan. It is designed to run on Windows Operating Systems. ClearCheck Model RADCC V2 performs calculations on the incoming supported treatment data. Supported Treatment Planning Systems are used by trained medical professionals to simulate radiation therapy treatments for malignant or benign diseases.
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    K Number
    K220582
    Device Name
    ClearCalc Model RADCA V2
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2022-08-22

    (174 days)

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

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
    Device Description
    The ClearCalc Model RADCA V2 device is software that uses treatment data, image data, and structure set data obtained from supported Treatment Planning System and Application Programming interfaces to perform a dose and/or monitor unit (MU) calculation on the incoming treatment planning parameters. It is designed to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
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    K Number
    K200323
    Device Name
    AutoContour
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2020-10-30

    (263 days)

    Product Code
    QKB
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AutoContour is intended to assist radiation treatment planners in contouring structures within medical images in preparation for radiation therapy treatment planning.
    Device Description
    AutoContour consists of 3 main components: 1. An "agent" service designed to run on the Windows Operating System that is configured by the user to monitor a network storage location for new CT datasets that are to be automatically uploaded to: 2. A cloud-based AutoContour automatic contouring service that produces initial contours and 3. A web application accessed via web browser which allows the user to perform registration with other image sets as well as review, edit, and export the structure set containing the contours.
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    K Number
    K201119
    Device Name
    ChartCheck
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2020-06-26

    (60 days)

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

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ChartCheck device is intended for the quality assessment of radiotherapy treatment plans and on treatment chart review.
    Device Description
    The ChartCheck device is software that enables trained radiation oncology personnel to perform quality assessments of treatment plans and treatment chart review utilizing plan, treatment, imaging, and documentation data obtained from the ARIA Radiation Therapy Management database. ChartCheck contains 3 main components: - 1. An agent service that is configured by the user to monitor their ARIA Radiation Therapy Management database. The agent watches for new treatment plans, treatment records, documentation, and imaging data. The agent uploads new data to the cloud based checking service. - 2. A cloud based checking service calculates check states as new records are uploaded from the agent. - 3. A web application accessed via a web browser which contains several components. - a. It allows trained radiation oncology personnel to review treatment records, view the check state calculation results, record comments,, and mark the chart checks as approved. - b. It allows an administrator to set check state colors, configure default settings, and define check state logic.
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    K Number
    K193640
    Device Name
    ClearCalc
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2020-04-09

    (104 days)

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

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearCalc is intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
    Device Description
    The ClearCalc device (model RADCA) is software intended to assist users in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation. The treatment plans are obtained from supported Treatment Planning System and Application Programming interfaces. It is designed to run on the Windows Operating System. ClearCalc performs calculations on the treatment plan data obtained from supported Treatment Planning System and Application Programming interfaces. A Treatment Planning System is software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.
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    K Number
    K171352
    Device Name
    EZFluence
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2017-12-01

    (206 days)

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

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.
    Device Description
    The EZFluence device (model RADEZ) is software is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields. Inputs are obtained from plan and patient data obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. EZFluence runs as a dynamic link library (DLL) plugin to Varian Eclipse. It is designed to run on the Windows Operating System. EZFluence performs calculations on the plan obtained from Eclipse TPS (Version 13.5 (K141283) and Version 13.7 (K152393)) which is a software device used by trained medical professionals to design and simulate radiation therapy treatment plans for malignant or benign diseases.
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    K Number
    K171350
    Device Name
    Collision Check
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2017-11-29

    (204 days)

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

    Radformation, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CollisionCheck is intended to assist radiation treatment planners in predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures.
    Device Description
    The CollisionCheck device (model RADCO) is software intended to assist users to identify where collisions between the treatment machine and the patient or support structures may occur in a treatment plan. The treatment plans are obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. CollisionCheck runs as a dynamic link library (DLL) plugin to Varian Eclipse. It is designed to run on the Windows Operating System. CollisionCheck performs calculations on the plan obtained from Eclipse TPS (Version 12 (K131891), Version 13.5 (K141283), and Version 13.7 (K152393) which is a software used by trained medical professionals to install and simulate radiation therapy treatments for malignant or benign diseases.
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