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510(k) Data Aggregation

    K Number
    K233395
    Device Name
    Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
    Manufacturer
    Alliage S/A Industrias Médico Odontológica
    Date Cleared
    2024-01-03

    (92 days)

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

    Alliage S/A Industrias Médico Odontológica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral dental X-ray source to produce X-ray images using intraoral image receptors.
    Device Description
    These are hand-held portable battery operated x-ray generators for dental purposes. The Portable Dental X-Ray is an X radiation controlled emissions generator system, i.e., once put into service, is intended to be moved from one location to another by a person, used together with appropriate capture devices to generate intraoral radiological images for dental assessment, diagnosis and treatment. This equipment has exposure programs that can be applied to a variety of patients and has predefined exposure parameters depending on the type of patient. The operator is free to change these parameters depending on the situation. The equipment's human-machine interface consists of a control panel located on the top of the equipment, a local trigger button and a remote trigger (hard wired). The triggers are "dead-man" triggers, meaning they release and interrupt the exposure. The Portable Dental X-Ray was designed to be used in adult and children patients by trained dentists and dental technicians to produce X-ray images for diagnosis. The Portable Dental X-Ray is indicated for the production of intraoral medical images of teeth, mandible and oral structures; it assists in the diagnosis of diseases, planning of surgical treatment and monitoring. It is exclusively for dental use, and must be used and handled by qualified and trained health professionals according to the User Manual.
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