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510(k) Data Aggregation

    K Number
    K213526
    Device Name
    Aurora-RT
    Date Cleared
    2022-05-04

    (181 days)

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

    MagnetTx Oncology Solutions Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
    Device Description
    Aurora-RT is a medical device for image-guided radiation therapy (IGRT) that combines magnetic resonance imaging (MRI) with radiotherapy technology. It combines a 6 MV medical linear accelerator (Linac) and 0.5 T cryogenless superconducting MRI system mounted in a rotating gantry frame. The MR imaging capability is utilized for positioning the patient at the start of radiation therapy in place of computed tomography (CT) imaging that is commonly used in radiation therapy. MR imaging offers superior soft tissue contrast compared to CT and does not utilize ionizing radiation as with CT images.
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