510(k) K250655
K250655 is an FDA 510(k) premarket notification submitted by Digestaid - Artificial Intelligence Development SA for the device "Deep Capsule® (Deep Capsule US)". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device), a Class II device regulated under 21 CFR 876.1540.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2026
- Date Received
- March 5, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Device Class
- Class II
- Regulation Number
- 876.1540
- Review Panel
- GU
- Submission Type
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.