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    K Number
    K983564
    Device Name
    PRODIGY TOTAL BODY SOFTWARE
    Manufacturer
    LUNAR CORP.
    Date Cleared
    1998-12-08

    (56 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K935454
    Why did this record match?
    Device Name :

    PRODIGY TOTAL BODY SOFTWARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Total Body Software is used with the Prodigy bone densitometer system. This software provides an estimate of BMD, fat and lean tissue mass. The BMD value can then be compared to a reference population at the sole discretion of the physician.

    Device Description

    The Total Body Software for the Prodigy bone densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2), lean and fat tissue mass of the total body.

    AI/ML Overview

    Acceptance Criteria and Study for Prodigy Total Body Software:

    This device is a bone densitometer software, and its primary function is to provide estimations of Bone Mineral Density (BMD), lean tissue mass, and fat tissue mass. The acceptance criteria and supporting study focus on the correlation and precision of these measurements compared to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Correlation with predicate device (LUNAR DPX) for BMD estimations.r > 0.98 with the DPX.
    Similarity of average BMD, lean, and fat tissue mass values compared to predicate device.Very similar to the results obtained on a DPX in 46 subjects.
    Short-term precision (%CV) in vivo for total body BMD.
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