BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Artemis, Artemis TPO, Artemis MX

    K Number: K222222 · Decision Oct 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    16
    Review Days
    444

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    Basic Information

    Device Name
    Artemis, Artemis TPO, Artemis MX
    K Number
    K222222
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eigen
    Date Received
    July 25, 2022
    Decision Date
    October 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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