# DEN230027: NaviCam ProScan

- Pathway: De Novo (Direct)
- Applicant: Ankon Technologies Co., Ltd.
- Decided: Dec 12, 2023 after 242 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K254230: CapsoView (CVV); CapsoCloud (CLD) (2026), 0 descendants of its own
- K250655: Deep Capsule® (Deep Capsule US) (2026), 0 descendants of its own

## Indications for use
NaviCam ProScan is an artificial intelligent (AI) 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 AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel capsule endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. This tool is not intended to replace clinical decision making.

Source page: https://510kreport.com/device/DEN230027
Methodology: https://510kreport.com/methodology