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510(k) Data Aggregation

    K Number
    K220689
    Device Name
    Vatech Clismile
    Manufacturer
    Rayence Co.,Ltd
    Date Cleared
    2022-05-06

    (58 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rayence Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vatech Clismile is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
    Device Description
    This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth, and is a selfligation bracket using a ceramic body and a metal cap made of a metal material. Shelf-life is not applicable because of the low likelihood of time-dependent product degradation.
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    K Number
    K183478
    Device Name
    ClearON Mobile
    Manufacturer
    Rayence Co.,Ltd
    Date Cleared
    2019-03-01

    (74 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Rayence Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clear On Mobile software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Clear on Mobel is not approved for mammography and is meant to be used by qualified medical personnel only. Clear On Mobile is complying with DICOM standards to assure optimum communications between network systems.
    Device Description
    ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database. It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.
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