Device typeEndoscopic video image interpretive unit: An electrically-powered computing unit intended to analyse endoscopic video images to automatically detect and localize suspected abnormalities and lesions (e.g., polyps) in real-time. It interfaces with an endoscopic video image processing unit and display monitor, and will typically use artificial intelligence (AI)/deep learning software to identify abnormalities and overlay visual flags/markers on video images to highlight regions of interest to clinicians.
FDA categoryGastrointesinal lesion software detection system
Device ID10884521855359
AvailabilityPrescription
LatexNot made with natural rubber latex
MRI safetyLabeling does not contain MRI Safety Information