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510(k) Data Aggregation

    K Number
    K211317
    Device Name
    CRUXVIEW
    Manufacturer
    CRUXELL Corp.
    Date Cleared
    2021-07-29

    (90 days)

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

    CRUXELL Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRUXVIEW is a software intended for using and managing dental x-ray image sent by Cruxcan image plate scanner, storing the images and allowing the user to process and examine the images in order to achieve improved diagnoses.
    Device Description
    The CRUXVIEW is dental x-ray image management software which provides various features to acquire, transfer, edit, display, and store scanned dental images which is specifically for a 510k cleared device (K183637), Cruxcan (CRX-1000). It also provides server/client model which allow users to upload and download the images and patient information from any workstations in the network environment. CRUXVIEW consists of two parts: CRUXVIEW Viewer and CRUXVIEW Server. CRX-1000 sends the scanned image to the CRUXVIEW viewer. The CRUXVIEW viewer sends the received image to the CRUXVIEW Server. The CRUXVIEW Viewer searches the image stored in the CRUXVIEW Server and shows the image to the user. The subject device has various functions for users' needs including length and angle measurement functions. The CRUXVIEW supports DICOM file formats.
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    K Number
    K183637
    Device Name
    Cruxcan (CRX-1000)
    Manufacturer
    Cruxell Corp.
    Date Cleared
    2019-02-12

    (48 days)

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

    Cruxell Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CRUXCAN (CRX-1000) is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.
    Device Description
    The CRUXCAN (CRX-1000) is a dental computed radiography system and is intended to produce digital X-Ray images for dental radiography purposes. It consists of a scanner, reusable imaging plates and workstation software. This device scans X-Ray exposed imaging plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for device operation. This device is intended to be operated in a radiological environment by qualified staff. The Imaging Plate is a polyester film made of densely applied particles of inorganic crystals called photostimulable phosphor. It is a flexible X-ray sensor for the CR system which can be used with a conventional medical X-ray imaging system and can be employed as a substitute for the screen/film system. The phosphor layer has a function of recording an X-ray image. This photostimulable phosphor is a special luminescent material which stores X-ray energy and emits light proportional to the stored X-ray energy when stimulation energy such as visible light is irradiated onto it. CRUXCAN TWAIN Driver and Viewer which transmit and display images are substantially equivalent to the predicate device software as well in terms of functions and principle of operations. The User interface is slightly different but the differences in design do not raise questions in device effectiveness.
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