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510(k) Data Aggregation

    K Number
    K150929
    Device Name
    CareView 1500Cw X-ray Flat Panel Detectors
    Manufacturer
    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2015-08-04

    (120 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K122865
    Predicate For
    K153058,K162178,K163019,K172581
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CareView 1500Cw detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.

    Device Description

    CareView 1500Cw is a kind of wireless portable digital X-ray flat panel detectors which have 434mm×355mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally.

    The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.

    The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

    The detector can't provide feedback to the generator to terminate the x-ray exposure.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the CareView 1500Cw X-ray Flat Panel Detectors. It does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

    The document focuses on demonstrating substantial equivalence to a predicate device (ViVIX-S Wireless, K122865) based on:

    • Technological Characteristics: Comparing specifications like image matrix size, pixel pitch, effective imaging area, grayscale, spatial resolution, etc.
    • Nonclinical studies: Evaluation of parameters like Detective Quantum Efficiency (DQE), Modulation Transfer Function (MTF), noise power spectrum (NPS), spatial resolution, etc.
    • Clinical considerations: A "concurrence study of 30 clinical images" comparing the proposed device to the predicate.

    Therefore, I cannot provide the requested information for an AI/ML device as it is not present in the provided document. The device described is an X-ray flat panel detector, not an AI/ML-driven diagnostic tool.

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