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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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    K Number
    K090324
    Device Name
    ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
    Manufacturer
    STI MEDICAL SYSTEMS
    Date Cleared
    2010-12-20

    (679 days)

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

    STI MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UltraSightHD™ with ImageSense™ 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.
    Device Description
    The UltraSight HD™ Digital Colposcopy System with ImageSense™ Technology is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. ImageSense™ is an image processing suite available for the UltraSightHD™ digital colposcope. The ImageSense™ suite consists of two different modules: UltraGreen™ filter and Acetownite OpacityViewer™. The UltraGreen™ filter provides the user with greater contrast than an unprocessed image. UltraGreen™ is displayed as a reqular full color image, and is available to be used on any stillframe image displayed in the Review Hi-Res Imagery, View ImageSense Results, and Annotate lmage modes. The Acetowhite OpacityViewer™ compares two images, one taken prior to the application of Acetic Acid and an additional image taken 60 seconds after the application of Acetic Acid, otherwise known as the pre- and post- Acetic Acid images. The Acetowhite OpacityViewer™ then generates a difference map that shows the extent of white difference between the two images, which is indicated by a gradient color scale ranging from blue (no measurable difference between the images), through white (some difference) and vellow (moderate difference), to red (large difference). Red, on the difference map, indicates only the greatest color difference between the images. The illumination and optical design of the device allow the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms. ensuring that focused 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.
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    K Number
    K072691
    Device Name
    CERVICAL MD, MODEL C10
    Manufacturer
    STI MEDICAL SYSTEMS
    Date Cleared
    2008-01-31

    (129 days)

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

    STI MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cervical MD™ 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.
    Device Description
    Cervical MD 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 hiopsy. The illumination and optical design of the device allow the user to carture ligh resolution quality images. The optical subsystem is augmented by integrated image quality assessment algorithms ensuring that focused, centered and balanced-contrast images are acquired. A liquid crystal display (LCD) provides a video display and user interface information. The acquired images can be transferred to a computer and viewed on a monitor.
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