# K250655: Deep Capsule® (Deep Capsule US)

- Pathway: 510(k) (Traditional)
- Applicant: Digestaid - Artificial Intelligence Development SA
- Decided: Mar 12, 2026 after 372 days
- Product code: QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device)
- Device class: 2
- Regulation: 21 CFR 876.1540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230027 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230027: NaviCam ProScan, Ankon Technologies Co., Ltd. (2023) Summary page 5.

## Indications for use
Deep Capsule® is an artificial intelligence (Al) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The clinician is responsible for conducting their own assessment of the findings of the Al-assisted reading through review of the entire video, as clinically appropriate. This tool is not intended to replace clinical decision-making.

Source page: https://510kreport.com/device/K250655
Methodology: https://510kreport.com/methodology