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510(k) Data Aggregation

    K Number
    K211350
    Device Name
    Bindex BI-2
    Manufacturer
    Bone Index Finland Ltd.
    Date Cleared
    2022-04-29

    (361 days)

    Product Code
    MUA
    Regulation Number
    892.1180
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bone Index Finland Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bindex measures apparent cortical bone thickness at the proximal tibia and can be used in conjunction with other clinical risk factors or patient characteristics as an aid to the physician in the diagnosis and other medical conditions leading to reduced bone strength and in the determination of fracture risk.
    Device Description
    The Bindex Bl-2 system consists of handheld ultrasound transducer and software. Bindex Bl-2 is connected to the USB port of a computer and controlled with computer software. Bindex Bl-2 is used for measurement of cortical bone thickness and it provides Density Index (DI), a parameter which estimates bone mineral density at the hip as measured with DXA. For measurements, gel is applied on skin and ultrasound transducer is manually placed on the measurement location. Standardized measurement location is at proximal tibia (1/3 length of tibia). Transducer is manually oriented perpendicularly to the surface of the cortical bone to achieve accepted measurement. Measurement is repeated five times at each measurement location. Finally, transducer is disinfected by wiping gel off with isopropyl alcohol moistened cloth. The associated accessories include: - . Measurement stick - Ultrasound gel (optional)
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