Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K152859
    Device Name
    Portable X-ray System (Model: MINIX-V / MINIX-S)
    Manufacturer
    DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012)
    Date Cleared
    2015-12-03

    (64 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral image receptors. Its use is intended for both adults and pediatric subjects.
    Device Description
    The portable x-ray system (Models: MINIX-V, MINIX-S) is an x-ray generating device which is mainly designed for dental examination (teeth and jaw). Operating principle is that the high voltage electricity is getting into x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and penetrates teeth and jaw, and makes x-ray images through image receptors (chemical film or digital sensor). Once the power is supplied from the rechargeable lithium-ion polymer battery pack, the inverter generates high frequency and high voltage. Boosted and rectified DC high voltage (MINIX-V: 70kV, MINIX-S: 60kV) is loaded onto the x-ray tube, and the tube generates x-ray. Micro control unit (MCU) and other control parts function to display data on LCD and control the system by the input information from user interface. When operator controlled (fixed amount of) x-ray is exposed to patient's teeth and jaw, clinician can examine the parts with processed images from intra-oral image receptors (analog film, digital phosphor plate or digital sensor). The Portable X-ray System (Models: MINIX-V, MINIX-S) is composed of an x-ray generating part with an x-ray tube, a device controller (Control PCB), a power controller (Power PCB), an user interface (LCD window), a beam limiting part (x-ray emitting cone), a backscatter shield, and a remote control switch (hand-switch). The Portable X-ray System (Models: MINIX-V, MINIX-S) is a diagnostic x-ray system, which is intended to be used by trained dentists or dental technicians. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, x-ray tube, electrical protective devices, and other elements. The system with high frequency x-ray provides sharp and clear images, and the total lead protection seal protects patients and dentists from leakage or scattered radiation from the device.
    Ask a Question

    Page 1 of 1