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510(k) Data Aggregation

    K Number
    K053258
    Device Name
    EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
    Manufacturer
    HITACHI MEDICAL CORP.
    Date Cleared
    2005-12-09

    (17 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K013723
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

    Device Description

    EUB-6500 Diagnostic Ultrasound Scanner

    AI/ML Overview

    The provided text outlines the intended use and modes of operation for various transducers of the Hitachi EUB-6500 Diagnostic Ultrasound Scanner. It does not contain information about acceptance criteria for a specific outcome, nor does it describe a study proving the device meets particular performance metrics.

    Instead, this document appears to be part of a 510(k) premarket notification to the FDA, detailing the intended uses for different transducers associated with the EUB-6500 system. The "E" and "P" notations in the tables indicate whether an intended clinical application and mode of operation was "Added under Appendix E" (meaning new for this submission) or "Previously Cleared" (referring to a previous submission, K013723).

    Therefore, I cannot provide the requested information as it is not present in the provided text. The document is a regulatory submission outlining intended uses, not a performance study.

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