Search Results
Found 1 results
510(k) Data Aggregation
K Number
DEN200055Device Name
GI Genius
Manufacturer
Cosmo Artificial Intelligence - AI, LTD
Date Cleared
2021-04-09
(213 days)
Product Code
QNP, ONP
Regulation Number
876.1520Why did this record match?
Applicant Name (Manufacturer) :
Cosmo Artificial Intelligence - AI, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The GI GENIUS™ is an artificial intelligence/machine learning (AI/ML) device system comprised of software, hardware, and accessories that is intended for polyp detection during standard white-light colonoscopy. The device system generates a video on the main endoscopy display that contains the original live video together with superimposed markers (in the form of green boxes) that appear when a lesion is detected.
The GI Genius takes the Serial Digital Interface (SDI) output stream from the video endoscope processor as an input and then generates an SDI output stream to the existing monitor/display system containing the original video stream with additional markers superimposed on it. In essence, the system is inserted into the video stream just prior to it being displayed to the user/operator.
Ask a Question
Page 1 of 1