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510(k) Data Aggregation

    K Number
    K221587
    Device Name
    DHX-70H, XTG-70H
    Manufacturer
    Date Cleared
    2023-03-03

    (275 days)

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

    DIGIMED Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
    Device Description
    The portable x-ray system (Model: DHX-70H, XTG-70H), is an x-ray generating device which is designed for dental examination. Each device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for supplying power to the circuit and apparatus in housing, and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patient and operator from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on optional stands or digital camera tripods.
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    K Number
    K220574
    Device Name
    HYBRID S70
    Manufacturer
    Date Cleared
    2022-04-22

    (53 days)

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

    Digimed Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HYBRID S70 is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
    Device Description
    The portable x-ray system HYBRID S70, is an x-ray generating device which is designed for dental examination. The device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for supplying power to the circuit and apparatus in housing, and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patient and operator from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on optional stands or digital camera tripods.
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    K Number
    K181891
    Device Name
    Portable X-ray System (Model: MiniX-V, Mini X-S)
    Manufacturer
    Date Cleared
    2018-08-10

    (28 days)

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

    Digimed Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on fixable stands as optional arms in user manual or digital camera tripods. Operating principle is that the high voltage electricity is getting into the x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and goes through teeth and jaw of patient, and makes x-ray images onto image receptors as a chemical film or a digital sensor. Once the user enters the desired tube voltage data in the numerical value (%) by means of the user interface and press the x-ray exposure button, the system generates mixed pulse voltage (MiniX-V: 70kV max, MiniX-S: 60kV max) from the transformed and boosted AC voltage through high voltage generator. So the user is able to obtain x-ray images of patients' teeth and jaws from the image receptors, and diagnose about the images.
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    K Number
    K152859
    Device Name
    Portable X-ray System (Model: MINIX-V / MINIX-S)
    Date Cleared
    2015-12-03

    (64 days)

    Product Code
    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 AuthorizedThirdparty
    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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