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510(k) Data Aggregation

    K Number
    K071234
    Device Name
    ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2007-06-29

    (57 days)

    Product Code
    OBJ
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F

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

    The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

    Device Description
    • 활 ISO 10993-1 Biocompatibility
    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or machine learning.

    The document is a 510(k) summary for the AcuNav Diagnostic Ultrasound Catheter, stating its substantial equivalence to a previously marketed device. It primarily focuses on regulatory approval based on equivalence and safety testing (biocompatibility), not on performance metrics against specific acceptance criteria for diagnostic accuracy.

    Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, device performance, study methodology, or AI-related information. This information is simply not present in the provided text.

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