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510(k) Data Aggregation

    K Number
    K133524
    Device Name
    PVMED DDR 2430T
    Manufacturer
    PORTAVISION MEDICAL LLC
    Date Cleared
    2014-04-16

    (152 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended for use in generating radiographic images of neonatal anatomy. It is intended to replace radiographic film/ screen or CR systems in neonatal general-purpose diagnostic procedures. This device is not intended for mammography applications.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the Pvmed ddr 2430t. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The document primarily focuses on:

    • The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
    • Information related to regulatory compliance for the device.
    • Indications for Use: Generating radiographic images of neonatal anatomy, replacing film/screen or CR systems in neonatal general-purpose diagnostic procedures, and specifically stating it is not for mammography applications.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and the study details as this information is not present in the provided text.

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