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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
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QuickRayPRO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain information on acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the QuickRayPRO device, which is a dental intra-oral radiology image acquisition system, and primarily discusses regulatory aspects and indications for use. Therefore, I cannot generate the requested table and information.

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