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510(k) Data Aggregation

    K Number
    K971489
    Device Name
    RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Date Cleared
    1997-07-03

    (71 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K923813
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Rotational Angiography Option for Philips MultiDIAGNOST 4 is indicated for use in Angiographic diagnostic imaging examinations.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) pre-market notification for the Philips MultiDIAGNOST 4 - Rotational Angiography Option. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines regulatory compliance. It does not contain information regarding acceptance criteria or the study details typically associated with AI/ML device performance evaluation.

    Therefore, I cannot extract the requested information as it is not present in the provided document.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Details about experts used for ground truth establishment or their qualifications.
    4. Adjudication methods.
    5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
    6. Standalone algorithm performance.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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