AI devices with FDA product code QNP — Gastrointesinal Lesion Software Detection System
Product code QNP (“Gastrointesinal Lesion Software Detection System” in openFDA) covers 20 devices on the FDA AI-enabled list, from 11 companies. Most are reviewed by the Gastroenterology-Urology panel (20). The most recent decision was GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) on May 29, 2026.
20AI devices
7Companies
2021First decision
2026-05-29Latest decision
Trend: devices per year
202120222023202420252026
Top companies
All 20 devices, newest first
- GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd. · Gastroenterology-Urology
- MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd. · Gastroenterology-Urology
- SKOUT systemIterative Health · Gastroenterology-Urology
- MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd. · Gastroenterology-Urology
- CADDIEOdin Medical Limited · Gastroenterology-Urology
- SKOUT systemIterative Health · Gastroenterology-Urology
- MAGENTIQ-COLO (ME-APDS)Magentiq Eye LTD · Gastroenterology-Urology
- GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)Cosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- CADDIEOdin Medical Limited · Gastroenterology-Urology
- SKOUT® systemIterative Scopes, Inc. · Gastroenterology-Urology
- SKOUT® systemIterative Scopes, Inc. · Gastroenterology-Urology
- GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)Cosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- EW10-EC02 Endoscopy Support ProgramFUJIFILM Corporation · Gastroenterology-Urology
- ME-APDS; MAGENTIQ-COLOMagentiq Eye LTD · Gastroenterology-Urology
- GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- SKOUT® systemIterative Scopes Inc. · Gastroenterology-Urology
- SKOUT SoftwareIterative Scopes Inc. · Gastroenterology-Urology
- EndoScreenerChengdu Wision Medical Device Co., LTD. · Gastroenterology-Urology
- GI GeniusCosmo Artificial Intelligence - AI Ltd · Gastroenterology-Urology
- GI GeniusCosmo Artificial Intelligence - AI, LTD · Gastroenterology-Urology