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510(k) Data Aggregation

    K Number
    K061153
    Device Name
    GYNESONICS EC6 TRANSDUCER
    Manufacturer
    GYNESONICS, INC.
    Date Cleared
    2006-10-27

    (184 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K043278
    Why did this record match?
    Device Name :

    GYNESONICS EC6 TRANSDUCER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GYNESONICS EC6 Ultrasound Transducer is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

    Device Description

    The GYNESONICS Model EC6 Ultrasound Transducer is intended for use with the TERATECH t3000, a portable ultrasound imaging system.

    AI/ML Overview

    The provided text describes a 510(k) Summary for a medical device, the GYNESONICS Model EC6 Probe, which is a diagnostic ultrasound transducer. The document focuses on establishing substantial equivalence to predicate devices and detailing the intended use and technical specifications. It does not contain information about acceptance criteria for performance, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested information from the given text. The text does not elaborate on a study demonstrating the device's meeting of acceptance criteria.

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