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510(k) Data Aggregation

    K Number
    K022911
    Device Name
    MODEL AMI1200 C-ARM
    Manufacturer
    INTEGRITY PRACTICE MANAGEMENT, INC.
    Date Cleared
    2002-12-02

    (90 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 AMI1200 is intended to be used only by licensed practitioners; to produce imaging techniques required, providing the patient with an adequate diagnosis of their presented condition.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the AMII200 C-Arm, an image-intensified fluoroscopic x-ray system. This type of document confirms that the device is "substantially equivalent" to predicate devices already on the market, allowing it to be marketed.

    However, this letter does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. These details are typically found in the original 510(k) submission, which is a much more extensive technical document that is not appended to this FDA clearance letter.

    Therefore, I cannot fulfill your request using the information provided in this document. The letter simply states that the FDA reviewed the submission and determined substantial equivalence based on the information provided by the manufacturer.

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