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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 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.
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    K Number
    K103600
    Device Name
    PORTABLE X-RAY SYSTEM
    Manufacturer
    DIGIMED CORPORATION
    Date Cleared
    2011-04-08

    (121 days)

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

    DIGIMED CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
    Device Description
    The Portable X-ray System (Model: BIOX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose teeth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates teeth and jaw, and makes X-ray images on a receptor (chemical film or digital sensor). The Portable X-ray System (Model: BIOX) 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 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 portable X-ray system (Model: BIOX) provides sharp and clear images and protects patients and dentists from leakage radiation by using a lead protective seal.
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    K Number
    K082167
    Device Name
    PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
    Manufacturer
    DIGIMED CORPORATION
    Date Cleared
    2008-09-26

    (57 days)

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

    DIGIMED CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
    Device Description
    The Portable X-ray System (Model: DIOX-602, PROX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose of tooth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor). The Portable X-ray System (Model: DIOX-602, PROX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral xray source for producing diagnostic x-ray images using intra-oral image receptors. 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 portable X-ray system (Model: DIOX-602, PROX) provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.
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