Device class
Class II
Regulation 876.1540
Total clearances
3
2023-12-12 → 2026-09-25
Definition
What is Gastrointestinal Capsule Endoscopy Analysis Software Device
A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1540
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Ankon Technologies Co., Ltd. |
1 |
0 |
2023-12-12 |
|
CapsoVision, Inc.
|
1 |
1 |
2026-09-25 |
|
Digestaid - Artificial Intelligence Development SA |
1 |
1 |
2026-03-12 |
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 |
| 91110 |
CPT
|
— |
High
|
Capsule endoscopy, esophagus through ileum, with interpretation |
| 91111 |
CPT
|
— |
High
|
Capsule endoscopy, analysis and physician interpretation of recorded data |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-25 |
K254230 |
CapsoVision, Inc.
|
CapsoView (CVV); CapsoCloud (CLD) |
| 2026-03-12 |
K250655 |
Digestaid - Artificial Intelligence Development SA
|
Deep Capsule® (Deep Capsule US) |
| 2023-12-12 |
DEN230027 |
Ankon Technologies Co., Ltd.
|
NaviCam ProScan |