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510(k) Data Aggregation

    K Number
    K143493
    Device Name
    SignosRT Bladder Ultrasound System
    Manufacturer
    Signostics Ltd
    Date Cleared
    2015-01-14

    (36 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Signostics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Signos RT Bladder scanner projects ultrasound energy through the lower abdomen of a patient to obtain an image of the bladder that is used to non-invasively determine bladder volume. Users must have ultrasound training before using the device.
    Device Description
    The Signostics Ltd SignosRT Bladder is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode on an LCD display to enable non-invasive volume measurement of a patients bladder.
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