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510(k) Data Aggregation

    K Number
    K100531
    Device Name
    VISCOPE, MODEL 100P,100S
    Manufacturer
    HD MEDICAL SERVICES (INDIA) PVT.LTD
    Date Cleared
    2010-07-21

    (147 days)

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

    HD MEDICAL SERVICES (INDIA) PVT.LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViScope Electronic Stethoscope is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
    Device Description
    The ViScope Electronic Stethoscope (ViScope) is an audio-visual auscultation tool for quick and effective auscultation of a patient to aid the healthcare professional as necessary during patient care and/or for triage purposes. The ViScope is a Visual Phono Cardio Gram (VPCG) with visual display on which the heart sounds are represented as waveforms, which medical practitioners recognize and understand. The ViScope, similar to most electronic stethoscopes, has switchable modes (Bell/Dia/wide) for hearing heart, lung, blood vessel, enteral and other body sounds with different frequency ranges. In addition, the ViScope has an incorporated 'memory' feature that provides the user with the ability to review the saved 4 waveforms. The user also has the option to delete each waveform individually. The ViScope comes in two models. the ViScope 100S and the ViScope 100P. The models are the same device (design, technology, operation, manufacture, use, labeling, etc). The only difference is that the ViScope 100P has the ability to download data to a PC or printer, the ViScope 100S does not offer this download feature. The ViScope 100P is supported by software that can be installed in a PC. The user can see the real-time waveforms on the PC monitor (as live data) and record in 10 second intervals. The software allows the user with an option of selecting the entire 10 second signal or select any 3.5 seconds within the 10 second signal for a more detailed view. These selected signals can be saved with patient name, auscultation region, along with age & sex. The software tools such as zoom, calipers, and player functions can be used on the saved signals for further analysis. The saved signals can be printed from the PC or directly from the ViScope 100P.
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