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510(k) Data Aggregation

    K Number
    K242825
    Device Name
    Prenuvo Body Composition
    Manufacturer
    Prenuvo
    Date Cleared
    2025-01-17

    (121 days)

    Product Code
    LNHQIH
    Regulation Number
    892.1000
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    Applicant Name (Manufacturer) :

    Prenuvo

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prenuvo Body Composition is a software medical device (SaMD) which is intended for non-invasive fat, muscle and organ quantification. Designed to utilize DICOM-compliant magnetic-resonance image datasets acquired from compatible MR Systems, it displays the internal structure of the body, including the liver. Other physical parameters derived from the images may also be produced. All reported metrics in the Body Composition Report are known in the practice of medicine. Prenuvo Body Composition is indicated for individuals age 18 years and above.
    Device Description
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