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510(k) Data Aggregation

    K Number
    K213282
    Device Name
    ERI Handheld Dental X-ray System (Model AG100)
    Manufacturer
    Energy Resources International Co., Ltd. Hsinchu Branch
    Date Cleared
    2022-04-04

    (185 days)

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

    Energy Resources International Co., Ltd. Hsinchu Branch

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ERI Handheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images.
    Device Description
    It can be used with computed radiography (CR) detection film, digital radiography (DR) detection film or traditional film (dental film) to take intraoral X-rays and provide the information needed by the dentist for diagnosis. As a preoperative, intraoperative, and postoperative evaluation for identifying dental caries or auxiliary root canal treatment, as well as confirming the position of the implant during dental implant surgery. It can take pictures of the front and back teeth, as well as the bite of the back teeth. Applicable objects include adults and children. Due to the medical software included in radiation-emitting device. ERI handheld system is of Moderate level of concern.
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