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510(k) Data Aggregation

    K Number
    K231202
    Device Name
    QuickRayPRO
    Manufacturer
    Denterprise International Inc.
    Date Cleared
    2023-06-22

    (56 days)

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

    Denterprise International Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The QuickRayPRO shall be operated by healthcare professionals , who are educated and competent to perform the acquisition of dental intra-oral radiographs. The QuickRayPRO can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.
    Device Description
    QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images.
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