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510(k) Data Aggregation

    K Number
    K173265
    Device Name
    UltraVision 2 Diagnostic Ultrasound System
    Manufacturer
    WinProbe Corporation
    Date Cleared
    2017-11-07

    (27 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    WinProbe Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for peripheral vessel, abdominal, and superficial muscular skeletal diagnosis. The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
    Device Description
    The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode, M-Mode, Color Flow Doppler Mode, Pulsed Wave Doppler Mode, and E-Mode.
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    K Number
    K150580
    Device Name
    UltraVision 2 Diagnostic Ultrasound System
    Manufacturer
    WINPROBE CORPORATION
    Date Cleared
    2015-04-07

    (29 days)

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

    WINPROBE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients. (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis. The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
    Device Description
    The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode and.
    Ask a Question

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