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510(k) Data Aggregation

    K Number
    K250986
    Date Cleared
    2025-09-12

    (165 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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