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510(k) Data Aggregation

    K Number
    K102949
    Device Name
    COLONOSCOPY ASSISTANT
    Manufacturer
    STI MEDICAL SYSTEMS, LLC
    Date Cleared
    2011-06-15

    (253 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    STI MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This software is an accessory to standard colonoscopy. It is intended for use in the viewing, recording, archival, localization, documentation, and retrieval of still images, video, and patient data during and after a standard colonoscopic procedure. Standard colonoscopy is indicated for the evaluation of results from an abnormality on barium enema or other imaging study, unexplained gastrointestinal bleeding, screening and surveillance for colonic neoplasia, the excision of a colonic polyp, or the management of chronic inflammatory bowel disease. Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis.
    Device Description
    Colonoscopy Assistant is a software application designed to provide a streamlined clinical user interface for colonoscopy. The software serves as a portal to useful information before, during, and after a colonoscopic exam. The software displays live video from the colonoscope, enables high-resolution image capture, provides digital noise reduction, displays side-by-side playback of previous exams, estimates the scope camera location during a colon video, and stores all patient and exam information.
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    K Number
    K110147
    Device Name
    ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
    Manufacturer
    STI MEDICAL SYSTEMS, LLC
    Date Cleared
    2011-04-08

    (80 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    STI MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraSightHD™ C31 with ImageSense™ and Remote Viewer Telemedicine is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The Remote Viewer Telemedicine Technology is a software feature that enables medical personnel to view live video from the UltrasightHD during an ongoing medical exam from a remote viewing station.
    Device Description
    The UltraSightHD™ C31 Digital Colposcopy System with ImageSense™ and Remote Viewer Telemedicine Technologies represents a modification to the UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology. It is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy. The illumination and optical design of the device enable the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms, ensuring that focused, centered, and balanced-contrast images are acquired. Two liquid crystal displays (LCDs) provide video display and user interface information. The software includes functionality for annotating, filtering and storing the images on external PACS servers via the DICOM protocol. The ImageSense™ filters highlight certain characteristics of the captured images. The Remote Viewer Telemedicine feature enables medical personnel to view live video of an ongoing medical exam from a remote viewing station.
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