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    K Number
    K243864
    Device Name
    BONX805
    Manufacturer
    BONTECH Co., Ltd.
    Date Cleared
    2025-09-12

    (269 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K212144
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BONX805 is a portable X-ray system for diagnostic imaging of body extremities.

    Intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

    Device Description

    BONX805 is portable X-ray unit integrated with small computer. BONX805 goes with you no matter where the patient is (hospitals, clinics, nursing home and out-of-office mobile use). One unit can serve all the operators in your practice. BONX805 was designed to help doctors and radiologists for exact diagnosis with clear X-ray images and safety from unnecessary radiation exposure. This device shall be used in professional healthcare environment. An x-ray detector (necessary component for a fully-functional diagnostic system) is not part of the device.

    Basic functions of the subject device BONX805 are supported by software(firmware). The firmware of portable X-ray is a software which installed in product to operate BONX805. The firmware is installed in the hardware (embedded system). The firmware(Version: REV 1.00) controls the use mode and irradiation, also the firmware is expected to unchanged during its lifetime.

    BONX805 generates and controls X-rays using the power of the built-in battery, and irradiation is absolutely prohibited during charging. X-ray irradiation is controlled by the designed electronic circuit and MCU, and among the conditions necessary for shooting, the tube voltage is adjustable and the tube current is fixed. The irradiation time is set manually, and the value adjusted by the MCU electronically controls the semiconductor switching element. Using this X-ray, it passes through the body part to be diagnosed to obtain an image with a detector so that it can be used for diagnosis. The irradiation time setting method sets the irradiation time by the user turning the dial manually. After setting, press the exposure button.

    The BONX805 should be used with an X-ray detector, and this detector has a digital type and a film type. But the X-ray detector is not included in the BONX805 package.

    AI/ML Overview

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