BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    BioTraceIO Lite

    K Number: DEN230020 · Decision Dec 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    267

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    Basic Information

    Device Name
    BioTraceIO Lite
    K Number
    DEN230020
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.2052
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Techsomed Medical Technologies , Ltd.
    Date Received
    March 30, 2023
    Decision Date
    December 22, 2023
    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

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    BioTraceIO Precision (2.0)

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    Other Clearances by Techsomed Medical Technologies , Ltd.

    K Number Device Name
    K243084 BioTraceIO Precision (2.0)