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510(k) Data Aggregation

    K Number
    K111758
    Device Name
    CADENS (TM) COLON
    Date Cleared
    2012-02-14

    (237 days)

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

    DOG MICROSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CADENS™ Colon is a self-contained image analysis software package for evaluating CT volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-luminal view), the wall and the outside (extra-luminal view) of the colon. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue, with respect to their size, dimensions, shape and position. It is to be used only by trained and instructed health care professionals.
    Device Description
    Similar to the Siemens Syngo Colonography software package, VIATRONIX V3D Colon and VITAL Images CT Colonography, the CADENS™ Colon is indicated for use and designed for the support of authorized physicians in reviewing relevant CT scanner images of Colorectal Cancer patients. The CADENS™ Colon is similar in intended use to the above Siemens and VITAL Images solutions combined with the electronic cleansing intended use of the Viatronix medical device.
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