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

    BioTraceIO Precision (2.0)

    K Number: K243084 · Decision Dec 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    BioTraceIO Precision (2.0)
    K Number
    K243084
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2052
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Techsomed Medical Technologies , Ltd.
    Date Received
    September 30, 2024
    Decision Date
    December 27, 2024
    Product Code
    QZL
    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
    QZL Post-Ablation Tissue Response Prediction Software

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QZL), ordered by most recent decision date.

    BioTraceIO Lite

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Techsomed Medical Technologies , Ltd.

    K Number Device Name
    DEN230020 BioTraceIO Lite