GGI Genius (TM) System 200
GI Genius - GGS200
Device Description
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.
Environmental Conditions
- 101.00
- 75.00
- 90.00
- 20.00
- 104.00
- 50.00
- 101.00
- 75.00
- 90.00
- 20.00
- 104.00
- 14.00
Device Sizes
- Power Supply,100-240,VAC;Frequency,50-60,Hertz;Power,240,W;
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 10884521844544
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
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