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510(k) Data Aggregation

    K Number
    K221275
    Device Name
    Qraycam PRO
    Manufacturer
    Aiobio Co., Ltd.
    Date Cleared
    2024-09-04

    (856 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aiobio Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Qraycam PRO is intended to be used as an aid in the diagnosis of dental caries.
    Device Description
    Qraycam PRO is a fluorescence caries detection aid, designed to assist dentists and dental specialists in identifying caries areas during oral health examinations. The device produces images that can be displayed on an LCD screen attached to the main body or on a computer monitor.
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    K Number
    K183121
    Device Name
    Qraypen
    Manufacturer
    AIOBIO Co., Ltd.
    Date Cleared
    2019-07-18

    (251 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIOBIO Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Qraypen is to be used as an intraoral video source and is indicated for individuals who may benefit from the addition of video images in intraoral dental examinations.
    Device Description
    Qraypen, a Dental Intraoral Camera, provides digital color images of intraoral anatomy during oral health examinations by dentists or dental sub-specialists. The output of the images can be shown through a computer monitor. This product is designed only for the use in dentistry and may only be used by trained medical personnel. The Qraypen is not made as a caries detection device. Therefore, Qraypen is not claimed as a caries detection device. - (1) Main components of Oraypen Oraypen is a hand-held device that consists of Oraypen Handpiece, Cradle, Cradle screw, USB 2.0 Cable, Adapter, and User manual. The Qraypen is connected to a compatible Windows PC and power supply by USB 2.0 type cable. - (2) Design features - a) An intraoral camera that is capable of both blue and white LED color imaging - b) Integral LED that allows the color of light to be changed - c) Automatic focusing - d) Compatible with any viewer program that meets the standards of USB video device class (UVC) 1.0 or higher - (3) Three modes are available: - a) White light mode: Qraypen captures images with white LED color light - b) Blue light mode: Oraypen captures images with blue LED color light - c) Orange light mode: Qraypen captures images with white and Blue LED color light in succession
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