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510(k) Data Aggregation

    K Number
    K063312
    Device Name
    MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2006-11-30

    (28 days)

    Product Code
    DQO,ITX
    Regulation Number
    870.1200
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K050577
    Why did this record match?
    Device Name :

    MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942

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

    The Atlantis™ SR Pro 2 Coronary Imaging Catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the Boston Scientific Atlantis™ SR Pro 2 Coronary Imaging Catheter. It does not contain information about acceptance criteria, device performance, specifics of a study proving those criteria, ground truth establishment, or human-in-the-loop performance. It primarily focuses on regulatory information, such as predicate devices, classification, and indications for use.

    Therefore, I cannot extract the requested information from the provided text. The document is a regulatory filing, not a scientific study report describing performance metrics or validation methodologies.

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