Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K250790
    Device Name
    INNOVISION-DXII
    Manufacturer
    DK MEDICAL SYSTEMS Co., Ltd
    Date Cleared
    2025-08-01

    (140 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DK MEDICAL SYSTEMS Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250750
    Device Name
    INNOVISION-P5
    Manufacturer
    DK Medical Systems Co., Ltd
    Date Cleared
    2025-07-18

    (128 days)

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

    DK Medical Systems Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
    Device Description
    This portable X-ray system (Model: INNOVISION-P5) consists of an LCD display with up and down soft keys for controlling the kV settings. It includes a line-powered X-ray generator (transformer), an X-ray tube assembly, a collimator, a support stand, imaging processing software, and a digital flat-panel detector. The INNOVISION-P5 is a battery-operated, portable X-ray system designed for use with a flat-panel detector. The major components of the X-ray main unit include handle, enclosure, main control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), system control software running on the system control board, imaging processing software, and detector. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software displays 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 X-ray tube inside to emit X-rays, control the switch of the collimator, and monitor the working status of the device, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in facilities with portable or fixing sites. This INNOVISION-P5 is not intended for mammography. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. Under certain exposure conditions, the inverter generator irradiates X-rays and the X-rays penetrate the patient's body. The Software (Elui-P) and portable x-ray unit communicate via Bluetooth to send/receive data to operate the product. The X-ray information is turned into electrical signals by a detector. The electrical signals are magnified and converted into digital signals to create image data. The image is sent to the image processing software (Elui-P) via Wifi. This portable X-ray System is designed for handheld or stand-mounted imaging. Model INNOVISION-P5 can be configured to an optional portable stand that complies with IEC 60601- 1 safety standard. The recommended maximum load that the stand can safely carry is 6kgs to ensure the mechanical stability and effectiveness of the device.
    Ask a Question

    Page 1 of 1