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    K Number
    K962308
    Device Name
    EUB-905
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    1996-07-17

    (30 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EUB-905

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

    Not Found

    Device Description

    The Hitachi EUB-905 Ultrasound Electronic Scanner is Track1 diagnostic ultrasound system capable of the following operating modes: B, B/M and M mode. Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.

    AI/ML Overview

    The provided text describes basic safety and operational characteristics of the Hitachi EUB-905 Ultrasound Electronic Scanner but does not contain information about acceptance criteria or a study demonstrating device performance as requested.

    Therefore, I cannot populate the requested table or answer the specific questions regarding such a study. The document focuses on regulatory compliance regarding acoustic output and general electrical safety standards rather than clinical performance or efficacy.

    To answer your questions, I would need a different type of document, such as a clinical study report, a performance validation report, or a summary of clinical evidence that details specific performance metrics and the methodology used to assess them.

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