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510(k) Data Aggregation

    K Number
    K142329
    Device Name
    BBS REVOLUTION
    Manufacturer
    dBMEDx INC.
    Date Cleared
    2014-12-15

    (117 days)

    Product Code
    IYO,ITX
    Regulation Number
    892.1560
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BBS Revolution system projects ultrasound energy through the lower abdomen of the patient an image of the bladder, which is used to calculate bladder volume non-invasively.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the dBMEDx, Inc. BBS Revolution device. It does not contain information about acceptance criteria or a study that proves the device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

    Therefore, I cannot extract the requested information from the provided text.

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