The NaviCam XS Capsule/Tether is the NaviCam XS capsule with a Tether attached to allow the physicians to examine the esophagus prior to releasing the XS capsule into the stomach for a…
The NaviCam XS Capsule/Tether is the NaviCam XS capsule with a Tether attached to allow the physicians to examine the esophagus prior to releasing the XS capsule into the stomach for a small bowel examination.
Who Else Makes It
Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for NaviCam XS Capsule/Tether | Listed by | ANX Robotica Corp., United States |
| FDA product code | NEZ |
| Device type | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2026-02-09 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.