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510(k) Data Aggregation

    K Number
    K040213
    Device Name
    MHLX7EC TRANSDUCER
    Manufacturer
    MICROHELIX, INC.
    Date Cleared
    2004-09-22

    (236 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROHELIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MHLX7EC Transducer is intended for use in ultrasonic imaging of the human body. The Indications for Use table shows specific uses as abdominal, fetal, transrectal, and transvaginal. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Transrectal, Transvaginal.
    Device Description
    The Microhelix MHLX7EC is a replacement ultrasound transducer designed to be used with the Acuson 128XP and Acuson Aspen Systems. It consists of a lens and associated circuitry, a handle which fits around the lens, a cable with strain relief devices on both ends, and a connector to attach the transducer to the ultrasound console.
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