QKZ — Magnetically Maneuvered Capsule Endoscopy System Class II
Classification Details
- Product Code
- QKZ
- Device Class
- Class II
- Regulation Number
- 876.1310
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241934 | anx robotica | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) | July 31, 2024 |
| K231960 | anx robotica corporation | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) | October 3, 2023 |
| K230694 | anx robotica | NaviCam Xpress Stomach System, NaviCam Xpress System | April 13, 2023 |
| K221608 | anx robotica | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether | November 22, 2022 |
| K203192 | anx robotica | NaviCam Xpress Stomach System | May 4, 2021 |
| DEN190037 | anx robotica | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | May 22, 2020 |