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510(k) Data Aggregation

    K Number
    K180595
    Device Name
    SciMoCa
    Manufacturer
    Radialogica LLC
    Date Cleared
    2018-04-04

    (29 days)

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

    Radialogica LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
    Device Description
    SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
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