# K203192: NaviCam Xpress Stomach System

- Pathway: 510(k) (Traditional)
- Applicant: Anx Robotica Corp
- Decided: May 4, 2021 after 188 days
- Product code: QKZ (Magnetically Maneuvered Capsule Endoscopy System)
- Device class: 2
- Regulation: 21 CFR 876.1310
- 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 DEN190037 (2020). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190037: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule, Anx Robotica, Inc. (2020) Summary page 4.

## Most influential descendants
- K221608: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether (2022), 2 descendants of its own
- K231960: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether (2023), 1 descendant of its own
- K241934: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) (2024), 0 descendants of its own
- K230694: NaviCam Xpress Stomach System, NaviCam Xpress System (2023), 0 descendants of its own

## Indications for use
The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI <38. The system can be used in clinics and hospitals, including ER settings.

Source page: https://510kreport.com/device/K203192
Methodology: https://510kreport.com/methodology