Gastroenterology_urology
GI Genius
Cosmo Artificial Intelligence - AI Ltd
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.
FDA Submission Metadata
- Submission number
- K211951
- Decision date
- July 2021
- FDA panel
- Gastroenterology-Urology
- Product code
- QNP
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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