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510(k) Data Aggregation

    K Number
    K141539
    Device Name
    KUBTEC X250
    Manufacturer
    KUB TECHNOLOGIES, INC
    Date Cleared
    2014-10-29

    (141 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KUBTEC X250

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Kub250 is intended for us by a qualified/trained physician or technician for generating, and displaying diagnostic radiographic images of neonatal patients. The Kub250 is not intended for mammography applications.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter for the Kubtec X250 (Kub250) mobile x-ray system, stating that the device is substantially equivalent to a predicate device. It indicates the intended use of the device for generating and displaying diagnostic radiographic images of neonatal patients, excluding mammography applications. It does not contain information about acceptance criteria, device performance studies, or details about AI algorithms.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment based on this document.

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