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510(k) Data Aggregation

    K Number
    K961374
    Device Name
    PHILIPS MULTIDIAGNOST 4
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Date Cleared
    1996-08-19

    (132 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K023441,K030650,K033486
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MultiDIAGNOST 4 is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for the Philips MultiDIAGNOST 4, Universal Tilt C-Arm System, primarily focusing on its substantial equivalence to predicate devices and regulatory compliance. It does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications in the way typically required for AI/ML-driven medical devices.

    Therefore, I cannot provide the requested table and study details. The document is a regulatory approval document for a traditional X-ray system, not an AI/ML device, and thus does not include the type of performance evaluation data you are asking for.

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