BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Ablation-fit

    K Number: K222938 · Decision Sep 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    351

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    Basic Information

    Device Name
    Ablation-fit
    K Number
    K222938
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R.A.W. S.R.L
    Date Received
    September 26, 2022
    Decision Date
    September 12, 2023
    Product Code
    QTZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

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