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510(k) Data Aggregation

    K Number
    K964309
    Device Name
    SONOS 2000, SONOS 2500 (M2406 A)
    Manufacturer
    HEWLETT-PACKARD CO.
    Date Cleared
    1997-04-22

    (175 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K934041,K935009
    Why did this record match?
    Device Name :

    SONOS 2000, SONOS 2500 (M2406 A)

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

    No change from existing SONOS 2500 platform reviewed during 510(k) 934041

    Device Description

    This modification allows for transmission of an ultrasound signal at one frequency and receipt of the returning echo at a different frequency. A minor system modification is made to detect these harmonic echoes. New transducer, component modifications to two circuit boards and SW to recognize/drive the new transducer.

    AI/ML Overview

    The provided text does not contain information on acceptance criteria or a study proving device performance against such criteria. The document describes a 510(k) summary for a modification to an ultrasound imaging system (Sonos 2500) to enable harmonic imaging. It focuses on the technical aspects of the modification and its predicate devices, not on clinical performance studies or specific performance metrics.

    Therefore, I cannot fulfill the request to build the table and provide the details about a study, as this information is absent in the input.

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