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510(k) Data Aggregation

    K Number
    K053172
    Device Name
    UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)
    Manufacturer
    OWANDY SAS
    Date Cleared
    2006-06-09

    (207 days)

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

    OWANDY SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UNIVERSAL-X digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners. This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patients mouth instead of conventional film. The sensor , upon radiation exposure, automatically captures the images into a computer. The computer , which is not provided by OWANDY , controls all aspects of image acquisition and image display, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions. The main advantages of this digital imaging system are - high definition ensuring high-value diagnostics - interface allowing image processing in the PC In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The UNIVERSAL-X digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional X-ray tube and a Computer for dental radiographic imaging. The Universal-X is covered with a single use disposable sheath and positionned in the oral cavity opposite the tooth the dentists wishes to xray. The dental X-ray tube (which is not part of Universal-X) is pointed at the sensor and activated. The emitted radiation from the X-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to. In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.
    Device Description
    The UNIVERSAL-X system consists of the following components : the sensor and its cable, a data box, and a PC with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CCD. The sensor attaches the processing unit via a 3 meters cable. The outer dimensions are approximately 42.77 X 28.40 mm with rounded edocs. The datas/USB box relays the data to the computer for display. The data box is a 44.5 mm X 161.2 X 154 mm box with an USB cable connection. The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CCD). The resulting electronic signals are digitised and sent to a computer for image presentation.
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