GGI Genius (TM) System 100

GGI Genius (TM) System 100
GI Genius - GGS100

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.

• Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QNP

Device Name: Gastrointesinal Lesion Software Detection System

Device Class: 2

Physical State: The device is a software, which may contain hardware components for enabling compatibility with endoscopic devices.

Definition: A gastrointestinal lesion software detection system is 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 may contain hardware to support interfacing with an endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is a software that uses artificial intelligence/machine learning (AI/ML) advanced algorithms to aid in detection colonic mucosal lesions via endoscopy in real-time.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Gastrointestinal tract

Regulation Number: 876.1520

Third Party Flag: N

Medical Specialty: GU

Device Id: 10884521844537

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A