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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
    LNH,QIH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    Not Found

    AI/ML Overview

    The provided document does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Prenuvo Body Composition device, stating that it has been found substantially equivalent to legally marketed predicate devices. It also lists the Indications for Use for the device.

    To answer your request, I would need a different document that details the device's performance study and its pre-defined acceptance criteria.

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