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510(k) Data Aggregation

    K Number
    K211841
    Device Name
    MRI Planner
    Date Cleared
    2022-08-25

    (437 days)

    Product Code
    Regulation Number
    892.5050
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    Applicant Name (Manufacturer) :

    Spectronic Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process images from MRI systems to 1) provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning, and to 2) derive contours for input to radiation treatment planning by assisting in localization and definition of healthy anatomical structures. MRI Planner is not intended to automatically contour tumor clinical target volumes. MRI Planner is indicated for radiotherapy planning of adult patients for primary and metastatic cancers in the brain and head-neck regions, as well as soft tissue cancers in the pelvic region. MRI Planner generates synthetic CT images for radiation attenuation estimation purposes for the pelvis, brain and head-neck regions only. MRI Planner generates automatically derived contours of the bladder, colon and femoral heads, for prostate cancer patients only.
    Device Description
    The product MRI Planner is a stand-alone software providing information to the treatment planning process prior to radiotherapy. Based on a DICOM MR image stack, the software generates synthetic CT images that can be used for attenuation calculations in radiotherapy treatment planning for the pelvis, brain and head-neck regions. In addition, the software also generates contours of anatomical structures in the MR image stack, to be used as a starting point for the manual delineation work required in radiotherapy treatment planning. Contours are generated for prostate cancer patients only (bladder, colon and femoral heads). MRI Planner utilizes pre-trained machine learning models to perform both the conversion to synthetic CT and the automated structure contouring. The models for synthetic CT generation was trained using a dataset comprising MR and CT images for 244 patients acquired in the treatment position at four hospitals. The model for prostate cancer patient auto contouring was trained using a dataset comprising MR images for 175 patients acquired in the treatment position at four hospitals, together with in-house generated expert manual contours. MRI Planner does not display or store DICOM images. The user is advised to use existing softwares for radiotherapy treatment planning to display and modify generated images and contours. MRI Planner runs on a standard x86-64 compatible system with a CUDA capable NVIDIA GPU and requires Ubuntu Linux 18.04 operating system.
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