# K254230: CapsoView (CVV); CapsoCloud (CLD)

- Pathway: 510(k) (Traditional)
- Applicant: CapsoVision, Inc.
- Decided: Sep 25, 2026 after 270 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
CapsoView is a software application for the download, transcode, and review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports. CapsoCloud is a cloud-based software application for the review of videos from CapsoCam Plus Capsule Endoscopes, and the generation of capsule endoscopy reports. The software includes artificial intelligence (AI) tools for video analysis designed to aid clinicians in the review of small bowel capsule endoscopy images collected from adult and pediatric patients over two years of age, in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The “AI Highlights” tool aids small bowel capsule endoscopy reviewers by decreasing the time to review capsule endoscopy images. The “Suggested Landmarks” tool assists reviewers in the identification of the digestive tract location (esophagus, stomach, small bowel, and colon). The “Green Detection” tool identifies and sequesters obscured, uninterpretable frames (e.g., obscured by debris, bile, or bubbles) to streamline the review process. The AI tools are not intended to replace the clinician's diagnostic interpretation. Clinicians are responsible for conducting their own assessment of the AI-assisted findings by reviewing the entire video as clinically appropriate.

Source page: https://510kreport.com/device/K254230
Methodology: https://510kreport.com/methodology