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510(k) Data Aggregation

    K Number
    K233053
    Device Name
    DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
    Manufacturer
    Dental Imaging Technologies Corporation
    Date Cleared
    2023-11-21

    (57 days)

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

    Dental Imaging Technologies Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEXIS sensor is a USB- driven digital sensor which is intended to acquire dental intra- oral radiographic images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and aligmment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
    Device Description
    The DEXIS Sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Sensors support USB2.0 and USB 3.x connectivity to personal computers using a dedicated electronic assembly and a sensor software driver. The software and firmware for the subject device are similar to the software and firmware for the predicate device and both have a Moderate level of concern. The software performs only basic functions of image capture and transfer to a computer. The software does not perform any medical image manipulation such as image enhancements as these are expected to be performed in the dental viewing software(s) used in conjunction with the subject device. The subject device DEXIS sensor refers to the dental intra-oral detector. The x-ray generator (an essential component for a fullyfunctional dental x-ray system) is not part of the submission.
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