Anx Robotica Corp
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories2
Latest FDA decision2024-07-31
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | QKZ | 2024-07-31 | View |
| 510(k) | K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | QKZ | 2023-04-13 | View |
| 510(k) | 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 | QKZ | 2022-11-22 | View |
| 510(k) | K203192 | NaviCam Xpress Stomach System | QKZ | 2021-05-04 | View |
| 510(k) | K201106 | IntraMarX 3D Radiopaque Marker | FFX | 2020-05-21 | View |
| 510(k) | K191087 | IntraMarX Radiopaque Markers | FFX | 2019-12-18 | View |
No matching devices.
Related Clinical Trials
NCT04605302Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal SymptomsCOMPLETEDNCT07633847A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.NOT_YET_RECRUITINGNCT07649720NaviCam Patency Capsule to Verify Gastrointestinal PatencyNOT_YET_RECRUITING