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510(k) Data Aggregation

    K Number
    K052283
    Device Name
    HEART STG SYSTEM AND SOFTWARE
    Manufacturer
    STETHOGRAPHICS, INC.
    Date Cleared
    2005-12-23

    (123 days)

    Product Code
    DQD
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    STETHOGRAPHICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stethographics Heart STG is software intended to provide support to the physician in the evaluation of heart sounds in patients. The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs. The device is indicated for use in the clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It in not intended as a sole means of diagnosis. The interpretations of heart sounds offered by the Heart STG System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
    Device Description
    The Heart STG is software intended to provide support to medical personnel in the evaluation of heart sounds. The software records and analyzes an acoustic signal of the heart and aids the healthcare provider by marking S1, S2, and suspected systolic murmurs on the waveform. As a complete system the Heart STG system consists of an electronic stethoscope and software running on a computer with Windows operating system. The user must provide a compatible electronic stethoscope and a computer.
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    K Number
    K012387
    Device Name
    STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
    Manufacturer
    STETHOGRAPHICS, INC.
    Date Cleared
    2002-04-23

    (270 days)

    Product Code
    BZM
    Regulation Number
    868.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    STETHOGRAPHICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.
    Device Description
    The Stethographic STG Monitor Multichannel Lung Sound Analysis System Comprises Chest pad with electronic stethoscopes, back pad, pre-amplifier, connection hub, and a PC computer. The system also includes a printer, a cart, speakers, headphones, re-writable CDs for data storage and custom software. The system is non-invasive with patient contact disposable cotton cover.
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