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510(k) Data Aggregation

    K Number
    K252863

    Validate with FDA (Live)

    Device Name
    ClearCalc Model RADCA V2.6
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2025-12-19

    (101 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K220582
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 V2.6 device is software that uses treatment data, image data, and structure set data obtained from a 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.

    AI/ML Overview

    N/A

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