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510(k) Data Aggregation

    K Number
    K214091
    Device Name
    Dental Image Plate Scanner, Model DFC-4T-SMART
    Date Cleared
    2022-03-02

    (64 days)

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

    Hefei DentaFilm Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.
    Device Description
    The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan and process image data contained in the intraoral imaging plate. Once the intraoral imaging plate is inserted into the entrance of the scanner, the scanning program will be started to progressively scan the imaging plate, and move forward in the meantime to scan the imaging plate completely with the laser beam in a specified time. In the place where the laser is irradiated, blue fluorescence will be excited and the intensity of the fluorescence brightness is linearly related to the image data density at that point. The fluorescence will be collected by a high-efficiency photoconductor, which is positioned along the laser scanning line and then will be introduced into a photomultiplier tube, where it will be converted into a corresponding electrical signal. After the electrical signal is converted by A/D (analog/digital) converter in the electrical circuit, it can be used for digital image processing and then output to the image display, storage, or transmission communication system. This Dental Image Plate Scanner, Model DFC-4T-SMART mainly consists of image plate scanner, power adapter, intraoral imaging plate and Dental image plate scanner control system software (Version: V1.0). The image plate scanner is composed of lasers, optical scanners, photomultiplier tubes, amplifiers, A/D converters, image processing unit and output interfaces etc. Dental image plate scanner control system software (DFC software) is mainly used to acquire and display the image data of the intraoral imaging plate as well as used for patient management, examination management, image storage, image printing etc. Dental image plate scanner control system software (Version: V1.0) is of Moderate level of concern.
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