QNP · Gastrointesinal Lesion Software Detection System

Device class

Class II

Regulation 876.1520

Total clearances

2021-04-09 → 2026-08-07

Last 12 months

Unique sponsors

Definition

What is Gastrointesinal Lesion Software Detection System

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.

Classification details

Medical specialty

Gastroenterology, Urology

Review panel

Regulation number

876.1520

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Cosmo Artificial Intelligence - Ai, Ltd.	6	1	2026-05-29
Magentiq Eye, Ltd.	4	2	2026-04-03
Iterative Scopes, Inc.	4	0	2024-07-03
Odin Medical Limited	2	1	2025-09-12
Fujifilm Corporation	2	1	2026-08-07
Iterative Health	2	1	2025-12-22
Xiamen Inno Medical Technology Co., Ltd.	1	1	2026-08-05
Chengdu Wision Medical Device Co., Ltd.	1	0	2021-11-19

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
91020	CPT	—	High	Esophageal dilation procedures; with endoscopy
91110	CPT	—	High	Esophageal motility (manometric) studies and/or gastroesophageal reflux test (GERD)
45398	CPT	—	Medium	Colonoscopy, flexible, proximal to splenic flexure; with band ligation(s) of internal hemorrhoids

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-07	K260567	Fujifilm Corporation	EW10-EC02 Endoscopy Support Program
2026-08-05	K252853	Xiamen Inno Medical Technology Co., Ltd.	CAD - Lower GI (EC07-01)
2026-05-29	K261369	Cosmo Artificial Intelligence - Ai, Ltd.	GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)
2026-04-03	K260724	Magentiq Eye, Ltd.	MAGENTIQ-COLO (ME-APDS)
2025-12-22	K253664	Iterative Health	SKOUT system
2025-10-03	K252178	Magentiq Eye, Ltd.	MAGENTIQ-COLO (ME-APDS)
2025-09-12	K252586	Odin Medical Limited	CADDIE
2025-05-09	K251126	Iterative Health	SKOUT system
2025-01-24	K244023	Magentiq Eye, Ltd.	MAGENTIQ-COLO (ME-APDS)
2024-07-25	K241887	Cosmo Artificial Intelligence - Ai, Ltd.	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)
2024-07-24	K240044	Odin Medical Limited	CADDIE
2024-07-03	K241508	Iterative Scopes, Inc.	SKOUT® system
2024-04-19	K240781	Iterative Scopes, Inc.	SKOUT® system
2024-01-12	K233964	Cosmo Artificial Intelligence - Ai, Ltd.	GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
2023-12-15	K230751	Fujifilm Corporation	EW10-EC02 Endoscopy Support Program
2023-07-25	K223473	Magentiq Eye, Ltd.	ME-APDS; MAGENTIQ-COLO
2023-05-19	K231143	Cosmo Artificial Intelligence - Ai, Ltd.	GI Genius System 100 and GI Genius System 200
2023-04-07	K230658	Iterative Scopes, Inc.	SKOUT® system
2022-08-12	K213686	Iterative Scopes, Inc.	SKOUT Software
2021-11-19	K211326	Chengdu Wision Medical Device Co., Ltd.	EndoScreener
2021-07-23	K211951	Cosmo Artificial Intelligence - Ai, Ltd.	GI Genius
2021-04-09	DEN200055	Cosmo Artificial Intelligence - Ai, Ltd.	GI Genius