BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    myAblation Guide (VB80A)

    K Number: K240796 · Decision Aug 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    31
    Review Days
    137

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    Basic Information

    Device Name
    myAblation Guide (VB80A)
    K Number
    K240796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare GmbH
    Date Received
    March 22, 2024
    Decision Date
    August 6, 2024
    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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