BEUDAMED
    Product Code: QHX FDA class 1 21 CFR 892.1960

    Fluoroscopic X-Ray Image Intensifier

    Radiology

    The Fluoroscopic X-Ray Image Intensifier is a radiology device intended to instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density, enhancing the visibility of real-time x-ray images. It is classified as FDA Class 1, the lowest risk category subject to general controls, and is exempt from 510(k) premarket notification requirements. The product code is QHX, regulated under 21 CFR 892.1960, within the Radiology medical specialty. It is not flagged as an implant or life-sustaining device.

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    Basic Information

    Product Code
    QHX
    Device Class
    FDA class 1
    Regulation Number
    892.1960
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting

    Definition

    To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density.