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510(k) Data Aggregation

    K Number
    K122427
    Device Name
    CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE
    Manufacturer
    CARESTREAM DENTAL LLC
    Date Cleared
    2012-09-12

    (34 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARESTREAM DENTAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CS Orthodontic Imaging and CS OMS Imaging software is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images. including digital photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions.
    Device Description
    CS Orthodontic Imaging and CS OMS Imaging software is a modification of currently legally marketed Kodak Orthodontic and OMS Imaging v8.0 software (K043104). The software is intended for installation at orthodontic or oral surgery clinics and offices on general purpose off-the-shelf computers systems (PCs) running Microsoft Windows in a peer-to-peer network. Both the modified and unmodified devices consist of imaging software for orthodontic and oral surgery practices. The software provides the ability to connect satellite offices and may be marketed as a base system, with additional modules offered as options. The base system includes the storage, annotation and display of images. The optional Analysis module enables the user to trace the cephalometric x-rays using standard analyses. The optional Planner module enables the user to simulate orthodontic or surgical treatment in order to communicate treatment objectives or demonstrate and explain potential surgery to the patient. When used with Carestream's panoramic, cephalometric, and other imaging systems, the device provides an interface that enables the practitioner to acquire radiographic images of the dentomaxillofacial region. The software then allows the user to visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program. CS Orthodontic and OMS Imaging software includes records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data. The software also enables the user to retrieve an electronic copy of an x-ray image from other imaging systems. The device includes options for image viewing or presentation, including thumbnail viewing, single image viewing, and merging images into a letter (i.e., as part of a written communication to the patient). The image manipulation options include grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, d-speckle, hue, saturation, equalize, flip, mirror, masking, and rotate functions. Image annotation functions allow the user to add text to images, to measure distances and angles, magnify images, and other functions. CS Orthodontic and OMS Imaging software can be integrated with Carestream's dental and dental sub-specialty practice management system software or used as a stand-alone product.
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