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510(k) Data Aggregation

    K Number
    K143703
    Device Name
    NICAL SMART MICRO CR system for intraoral dental images
    Manufacturer
    NICAL SPA
    Date Cleared
    2015-03-18

    (79 days)

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

    NICAL SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NICAL SMART MICRO CR system for intraoral dental images is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
    Device Description
    The NICAL/SMART MICRO is a Computed Radiography System which produces the Xray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of the latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
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    K Number
    K053029
    Device Name
    NDR+/DIVA-D
    Manufacturer
    NICAL SPA
    Date Cleared
    2006-01-06

    (71 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    NICAL SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DIGITAL IMAGE ACQUISITION SYSTEM TO BE USED IN CONJUCTION WITH AN IMAGE INTESIFIER DURING RADIOGRAPHY OR FLUOROSCOPY X-RAY EXAMINATION TO CAPTURE IMAGES BY A CAMERA, DIGITALIZE THE IMAGE, REVIEW IMAGES AND FORMAT IMAGES ACCORDING TO DICOM PROTOCOL TO BE SENT THROUGH NETWORK CONNECTION
    Device Description
    The NICAL NDR+ is a digital image acquisition system to be used in conjunction with an image Intensifier during radiography or fluoroscopy x-ray examination to capture images by a camera, digitalize the image, review images and format images according to DICOM 3.0 protocol to be sent through network connection.
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