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510(k) Data Aggregation

    K Number
    K220822
    Device Name
    3D-SHAPER
    Manufacturer
    3D-Shaper Medical S.L
    Date Cleared
    2022-12-09

    (263 days)

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

    3D-Shaper Medical S.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    3D-SHAPER uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z, Buckling Ratio, cortical sBMD, trabecular vBMD and integral vBMD. 3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.
    Device Description
    3D-SHAPER is a software reconstructing in 3D, the shape and bone mineral density from 2D DXA images. The software incorporates a DXA-based 3D reconstruction and measures the distribution of bone mineral mass at specific cross sections of the hip. It provides physicians with estimates of the structural properties of the hip, such as densities or geometrical parameters. The software is not suitable for use with paediatric patients or for subjects with hip prosthesis such as total hip replacement prosthesis, hip resurfacing prosthesis or an osteosynthesis system, since the software has not been tested against these conditions. 3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement. The 3D-SHAPER® measurements include: Cortical surface Bone Mineral Density (Cortical sBMD, mg/cm2) Trabecular volumetric Bone Mineral Density (Trabecular vBMD, mg/cm³) Integral volumetric Bone Mineral Density (Integral vBMD, mg/cm³), the integral compartment being the union of the cortical and trabecular compartments. Hip structural measurements: Cross-Sectional Area (CSA, in cm²), Cross-Sectional Moment of Inertia (CSMI, in cm4), section modulus (Z, in cm3) and buckling Ratio (BR). Cortical sBMD, trabecular VBMD and integral vBMD are calculated at the total femur. CSA, CSMI, Z and BR are calculated in cross-sections at the neck, intertrochanteric region and lower shaft.
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