# K221590: NaviCam Small Bowel Capsule Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Ankon Technologies Co., Ltd.
- Decided: Dec 2, 2022 after 183 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to DEN010002 (2001). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System, Given Imaging, Ltd. (2013)

## Indications for use
The NaviCam Small Bowel Capsule Endoscopy System is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

Source page: https://510kreport.com/device/K221590
Methodology: https://510kreport.com/methodology