Model note · MCCE
AnX NaviCam Capsule Endoscope System
NaviCam is a magnetically controlled capsule endoscopy (MCCE) system: the patient swallows a camera capsule, and an operator steers it around the stomach with an external magnet on a motorised platform. It is used in clinics and hospitals as a sedation-free way to see the stomach and duodenum. It was the first system in its FDA device type, created through a De Novo in 2020.
The model
Maker, model and type.
- Maker
- AnX Robotica Corp.
- Model
- NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (and NaviCam Xpress Stomach System)
- Device type
- MCCE
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| System components | Ingestible capsule, data recorder (AKR-1) in a patient vest, locator (AKS-1) and controller (NaviEC-1000) | Source |
| Capsule size | 12 mm outer diameter, 28 mm long (NaviCam Stomach Capsule AKEM-11SW) | Source |
| Capsule imaging and power | CMOS sensor with LEDs and photoresistor around the lens; RF transmitter; two silver oxide batteries | Source |
| Controller | Console, translational and rotational platform, magnetic ball and examination bed | Source |
| Capsule control axes | X, Y and Z translation plus clockwise and anticlockwise rotation, in real time | Source |
| Capsule radio frequency (Xpress, 2024) | 915 MHz, changed from 2.4 GHz for lower SAR | Source |
| Capsule shelf life | 14 months; supplied sterile (ethylene oxide) | Source |
| Current indication (Xpress) | Stomach visualisation in patients 6 years or older, BMI 65 or less, waist 77 inches or less | Source |
| FDA classification | De Novo DEN190037, 21 CFR 876.1310, Class II, product code QKZ | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Safety
Safety warnings from the record.
- An MRI scan with the capsule still inside may damage the gut or abdomen; if excretion is not confirmed, the patient needs medical review and possibly an abdominal X-ray first. Source
- The external magnet can interact with ferromagnetic implants in patients and users. Source
- Capsule retention from obstruction, and aspiration of the capsule, are recognised risks. Source
- False negative and false positive findings are the main clinical risks named by FDA. Source
Sources
Where this note comes from.
- FDA De Novo decision summary DEN190037, NaviCam
- FDA 510(k) summary K241934, NaviCam Xpress Stomach System
- openFDA MAUDE problem counts, NaviCam
- openFDA recall search, NaviCam (no matches)
Not covered: The AnX Robotica website did not respond, and no public user or service manual was found, so frame rate, battery life, magnet strength and controller error messages are not included. There are no FDA recalls and very few MAUDE reports, so failing parts cannot be identified.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
MCCE