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510(k) Data Aggregation

    K Number
    K252547
    Date Cleared
    2025-10-28

    (77 days)

    Product Code
    Regulation Number
    892.2050
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.

    The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Microspheres dose vial selection.

    Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Microspheres. For post-TheraSphere Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Microspheres.

    Device Description

    The TheraSphere 360 Y-90 Management Platform is an end-to-end, browser-based platform that will host a wide range of resources (e.g. radioembolization activity calculations, ordering, tracking, and education) that support Authorized Users of TheraSphere Microspheres.

    The TheraSphere 360 Platform includes treatment planning functionality, activity calculation functionality, vial selection and ordering, and post-treatment analysis functionality. The treatment planning functionality and the activity calculation functionality include an interactive tool intended for calculating the activity of TheraSphere Microspheres required at the treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.

    The Vial Selector function allows users to select and order TheraSphere Microspheres dose vials from inventory that match desired results.

    The post-treatment analysis functionality is intended as an optional tool for post-treatment evaluation following TheraSphere Microspheres treatment.

    AI/ML Overview

    N/A

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