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510(k) Data Aggregation

    K Number
    K060178
    Device Name
    VIX WIN PRO
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Date Cleared
    2006-03-10

    (46 days)

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

    GENDEX DENTAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner
    Device Description
    Vix Win is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, treatment, analysis and saving of xray digital images from DenOptix ®, Visualix ® / GX-S, KaVo Dig eXam, Orthoralix DPI & DDE series imaging systems by Gendex ®. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from an intraoral or extraoral dental camera such as the AcuCam Concept IV and eZ1 series. When properly installed in your computer, VixWin lets you: - Control scanning and intake of x-ray images from image plates with the DenOptix . scanner (*). - Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S, 미 KaVo Dig eXam, Orthoralix DPI & DDE series systems (*). - View and capture color images from certain cameras, such as a dental camera, via a suitable video capture card (*). - Export and import digital images (such as those obtained by scanning a film) in several 프 standard file formats. - Process images with dental specific tools, to enhance their diagnostic value. 제 - Analyze and manipulate images in order to gather additional diagnostic information . which may not be immediately apparent on initial visual inspection. - Create a database of patients and easily store images in patient folders .. .
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    K Number
    K050255
    Device Name
    ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
    Manufacturer
    GENDEX DENTAL SYSTEMS
    Date Cleared
    2005-03-17

    (42 days)

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

    GENDEX DENTAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthoralix 8500 Panoramic Dental X-ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.
    Device Description
    The Orthoralix 8500 is a system for rotational panoramic radiography of the dentomaxillo-facial area. The system consists of: - Column to be mounted to the wall . - Motor-driven overhead assembly with controls for patient postioning, setting of . technique factors and radiographic projection geometry. - Cassette drvie system with flat cassette for 15 x 30 cm film . - X-ray tubehead, with DC power supply ● - Remote control box and handswitch ● During a panoramic exposure, the x-ray tubehead and cassette holder move around the patient's head. The beam from the x-fay tabe is commans locks the radiation scattered from the patient. Patient positioning is simple, accurate and consistent by means of three postioning lasers, a bite guide and head stabilizers. During the exposure, the patient postioning lasers, a bitc guite and nead backless. All movements for the panoramic remains still with e tholorized components retater traiser traotors, which are microprocessor controlled. Along wit the Standard Panoramic mode, the Orthoralix 8500 provides a special child Along with the Bandard Fanolania me adiation dosage to the child, and confining the image to the dentition.
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