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510(k) Data Aggregation

    K Number
    K033550
    Device Name
    DXL CALSCAN
    Manufacturer
    DEMETECH AB
    Date Cleared
    2004-05-05

    (175 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEMETECH AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DXL Calscan™ Bone Densitometer estimated bone mineral density (BMD) (g/cm²) for the region of the heel (os calcis). By comparing estimated BMD to a (grim ) for the region of the Rose (a T-score is calculated so that the physician, at his or her discretion, may assess fracture risk.
    Device Description
    The DXL Calscan™ Bone Densitometer estimates Bone Mineral Density (BMD) of the Os Calcis. THE DAL Calstan - Bone Densitometor Societator Sectionetry (DEXA). Heel width, measured by a The lectificiously is based on Dual Enorgy Artay Arage in the effects from soft and adipose tissues.
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