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510(k) Data Aggregation

    K Number
    K982345
    Device Name
    VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
    Manufacturer
    CARDIAC MARINERS, INC.
    Date Cleared
    1998-09-01

    (57 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cardiac Mariners, Inc. VASCO scanning beam digital x-ray System is THE Ourdlations, mor in generating real time fluoroscopic images in patients where medically indicated.

    Device Description

    VASCO SYSTEM

    AI/ML Overview

    The provided text is a 510(k) clearance letter and a Statement of Intended Use for the "Vasco Scanning Beam" digital x-ray system. This document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided input.

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