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510(k) Data Aggregation

    K Number
    K190234
    Device Name
    ODI HD Dental Sensor
    Date Cleared
    2019-03-01

    (23 days)

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

    CND Global Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
    Device Description
    The ODI HD Dental Sensors are electronic medical device intra-oral radiographic images. The sensor can be operated by Radiologists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the sensor may also be aligned with the assistance of the patient. The ODI HD Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium lodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The ODI HD Dental Sensors allow for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The ODI HD Dental Sensors support USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver. The subject device does not control the generator, it is only a receiver. The X-ray system and the software used are not a part of this submission.
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