DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images…
DATA RECORDER. The NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (“NaviCam Stomach System” in short), is a novel endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule to be controlled by an operator.
Who Else Makes It
Concentrated in Hubei (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for NaviCam Capsule Endoscope System | Listed by | ANX Robotica Corp., United States |
| FDA product code | QKZ |
| Device type | Magnetically Maneuvered Capsule Endoscopy System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1310 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | DEN190037 |
| Record published | 2020-12-08 |
| Record revised | 2023-01-13 (version 2) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
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.