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The SKOUT® system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The SKOUT® system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT® is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.

The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT® system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time. Users will primarily interact with the SKOUT® system by observing the software display, including the polyp detection box and device status indicator signal.

ME-APDS (Magentig Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting reqions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. ME-APDS is trained to process video images which may contain regions consistent with polyps. ME-APDS is limited for use with standard white-light endoscopy imaging only. ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.

ME-APDS™MAGENTIQ-COLO is intended to be used as an adjunct to the common video colonoscopy procedure. The system application aims to assist the endoscopist in identifying lesions, such as polyps, during the colonoscopy procedures in real time. The device is not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making. The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different types of mucosal abnormalities such as polyps. The output video with the detected lesions is presented on a separate screen, highlighting the suspicious areas on the original video. The user can also take snapshots of the videos, with and without the highlighting of the suspicious areas, record videos and view in full screen mode.

The CADDIE computer-assisted detection device is intended to assist the gastroenterologist in detecting suspected colorectal polyps only. The gastroenterologist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. CADDIE is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of action for patients. The CADDIE computer-assisted detection device is limited for use with standard white-light endoscopy imaging only.

CADDIE is cloud based artificial intelligence medical device software. CADDIE interfaces with the video feed generated by an endoscopic video processor during a colonoscopy procedure The software is intended to be used by trained and qualified healthcare professionals as an accompaniment to video endoscopy for the purpose of drawing attention to regions with visual characteristics consistent with colonic mucosal lesions (such as polyps and adenomas). CADDIE analyses the data from the endoscopic video processor in real-time and provides information to aid the endoscopist in detecting suspected colorectal polyps, if they are in the field of view of the endoscope. The areas highlighted by CADDIE are not to be interpreted as definite polyps or adenomas. The responsibility to make a decision as to whether or not a highlighted region contains a polyp or is an adenoma lies with the user. The endoscopist is responsible for reviewing CADDIE suspected polyp areas and confirming the presence or absence of a polyp and its classification based on their own medical judgement.

The SKOUT® system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The SKOUT® system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT® is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.

The SKOUT system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time. Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal.

The SKOUT® system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The SKOUT® system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT® suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT® is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT® is indicated for white light colonoscopy only.

The SKOUT® system is a software-based computer aided detection (CADe) system for the analysis of high-definition endoscopic video during colonoscopy procedures. The SKOUT system is intended to aid gastroenterologists with the detection of potential colorectal polyps during colonoscopy by providing an informational visual aid on the endoscopic monitor using trained software that processes the endoscopic video in real time. Users will primarily interact with the SKOUT system by observing the software display, including the polyp detection box and device status indicator signal.

The GI Genius™ system is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius™ computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.

GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology. GI Genius is composed of software (namely, ColonPRO™ 4.0) and hardware (namely, GI Genius™ Module 100 and 200). GI Genius™ Module 100 and 200 are compatible with Video Processors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) output ports and endoscopic display monitors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) input ports. GI Genius™ Module 200 is also compatible with Video Processors featuring the 4K UHD standard. The GI Genius system is connected between the video processor and the endoscopic display monitor. When first switched on, the endoscopic field of view is clearly identified by four corner markers, and a blinking green square indicator appears on the connected endoscopic display monitor to state that the system is ready to function. During live video streaming of the endoscopic video image, GI Genius generates a video output on the endoscopic display monitor that contains the original live video together with superimposed green square markers that will appear when a polyp or other lesion of interest is detected, accompanied by a short sound. These markers will not be visible when no lesion detection occurs. The operating principle of the subject device is identical to that of the predicate device, this being a computerassisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device includes hardware to support interfacing with video endoscopy systems and the accessories given by the footswitch and the USB K-switch.

This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.

The subject device represents application of AI technology to endoscopic images to assist in detecting the presence of potential lesions. This development greatly contributes to improving the quality of colonoscopy. In recent years, computer-aided diagnosis (CAD) systems employing AI technologies have been approved and marketed as radiological medical devices for use with computed tomography (CT), X-ray, magnetic resonance imaging (MRI), and mammogram diagnostic images. In endoscopy as well, many images for diagnosis are taken. Since increasing the polyp detection rate is also in demand, CAD systems for endoscopy are being actively developed. Against this background, the company has developed this software (EW10-EC02), a new AI-based CAD system, to support Health Care Provider (HCP) detection of large intestine polyps in colonoscopic images. EW10-EC02 detects suspected large intestine polyps in the endoscope video image in real-time.

The ME-APDS (Magentig Eye's Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. The ME-APDS is trained to process video images which may contain regions consistent with polyps. The ME-APDS is limited for use with standard white-light endoscopy imaging only. The ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.

The ME-APDS (Magentig Eve's Automatic Polvo Detection System) is intended to be used as an adjunct to the common video colonoscopy procedure. The system application aims to assist the endoscopist in identifying lesions, such as polyps, during the colonoscopy procedures in real time. The device is not intended to be used for diagnosis or characterization of lesions, and does not replace clinical decision making. The system acquires the digital video output signal from the local endoscopy camera and processes the video frames. It runs deep machine learning and additional supporting algorithms in real time on the video frames in order to detect and identify regions having characteristics consistent with different tvpes of mucosal abnormalities such as polyps. The output video with the detected lesions is presented on a separate touchscreen, supplied as part of the ME-APDS, highlighting the suspicious areas on the original video. The output of the system can also be presented on additional monitors in the procedure room using the 1x4 HDMI Splitter supplied with the system. The user can also take snapshots of the videos, with and without the highlighting of the suspicious areas, record videos and view in full screen mode.

The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.

GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology. GI Genius is compatible with Video Processors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) output ports and endoscopic display monitor featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) input ports. GI Genius is connected between the video processor and the endoscopic display monitor. When first switched on, the endoscopic field of view is clearly identified by four corner markers, and a blinking green square indicator appears on the connected endoscopic display monitor to state that the system is ready to function. During live video streaming of the endoscopic video image, GI Genius generates a video output on the endoscopic display monitor that contains the original live video together with superimposed green square markers that will appear when a polyp or other lesion of interest is detected, accompanied by a short sound. These markers will not be visible when no lesion detection occurs. The operating principle of the subject device is identical to that of the predicate device, this being a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device includes hardware to support interfacing with video endoscopy systems.