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510(k) Data Aggregation

    K Number
    K241996
    Device Name
    ULTRA 1040
    Manufacturer
    ECORAY Co., Ltd.
    Date Cleared
    2025-04-18

    (283 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    ECORAY Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTRA 1040 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the patient's extremities. This device is not intended for mammography.
    Device Description
    This Portable X-ray Unit (Model: ULTRA 1040) consists of the following major components: an X-ray main unit, an X-ray exposure hand switch and a battery charger and other components. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the battery charger is for charging the built-in battery in the X-ray main unit. The device can be used with an X-ray detector, a computer for receiving and detecting signal results and image processing software. The major components of the X-ray main unit include: handle, enclosure, control panel, system control board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the system control board. The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board and control the high-voltage tank to generate high-voltage to excite the ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators.
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