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510(k) Data Aggregation

    K Number
    K103608
    Device Name
    I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
    Manufacturer
    ELLEX, INC.
    Date Cleared
    2010-12-27

    (18 days)

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

    ELLEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eye Cubed V4 is indicated for use in ophthalmic imaging when the following conditions are present or suspected: - Cataracts - Retinal Detachments (a separation of the retina from the middle coat of the eyeball) - Orbital Lesions - Tumors - Foreign bodies - Inflammation - Vascular Irregularities Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic: A, B, M, PWD, CWD, Colour Doppler, Amplitude Doppler, Colour Velocity Imaging, Combined (specify), Other (specify) Specific transducer intended uses: Ophthalmic 40 MHz Anterior Segment B-scan transducer: Anterior 40 MHz B-scan imaging of the eye Ophthalmic 10 MHz Posterior Segment B-scan transducer: Posterior 10 MHz B-scan imaging of the eye Ophthalmic 10 MHz Biometric A-scan transducer: 10 MHz Biometric A-scan imaging of the eye Ophthalmic 8 MHz Diagnostic A-scan transducer: 8 MHz Diagnostic A-scan imaging of the eye Ophthalmic 20 MHz Anterior Segment B-scan transducer: Anterior 20 MHz B-scan imaging of the eye
    Device Description
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    K Number
    K083061
    Device Name
    ELLEX INNOVATIVE IMAGING EYE CUBED V4
    Manufacturer
    ELLEX, INC.
    Date Cleared
    2009-01-09

    (87 days)

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

    ELLEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Posterior 10MHz B-scan Imaging of the Eye; 10MHz Biometric A-scan Imaging of the Eye; 8MHz Diagnostic A-scan Imaging of the Eye; Anterior 20MHz B-scan Imaging of the Eye.
    Device Description
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