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510(k) Data Aggregation

    K Number
    K182165
    Device Name
    Color Doppler Ultrasound System; Model: mEye1 and mEye2
    Date Cleared
    2018-12-20

    (132 days)

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

    Shenzhen Well.D Medical Electronics Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B, M, PWD and Color Doppler modes.
    Device Description
    The Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the imaging operation modes of B, M, PWD and Color Doppler.
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    K Number
    K100079
    Device Name
    DIGITAL ULTRASOUND SCANNER
    Date Cleared
    2010-03-01

    (48 days)

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

    SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WED-3100 Digital Ultrasound Scanner is intended for diagnostic ultrasound imaging analysis for abdomen, gynecology, obstetric, urology, small-parts. The system is intended to use for the following type of studies: fetal, abdominal, pediatric, small organs, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate. The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.
    Device Description
    This equipment is high resolution linear/convex ultrasound scanning diagnostic equipment. It adopts micro-computer control and digital scan converter (DSC), digital beam-forming (DBF), real time dynamic aperture (RDA), real time dynamic receiving apodization, real time dynamic receiving focusing (DRF), Digital frequency scan (DFS), frame correlation technologies to endue its image with clarity, stability and high resolution.
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