BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    BioTraceIO Vision (V1.7)

    K Number: K251931 · Decision Sep 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    76

    Basic Information

    Device Name
    BioTraceIO Vision (V1.7)
    K Number
    K251931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techsomed Medical Technologies
    Date Received
    June 24, 2025
    Decision Date
    September 8, 2025
    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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