anxrobotics.com
anxtobotics.comMotiliCap GI Monitoring System
Anx Robotica Corporation
ANX ROBOTICA CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016544248 | 3016544248 | ANX ROBOTICA CORP. | 1 | Y | 2026-01-01 | 6010 W. Spring Creek Pkwy Plano TX US 75024 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810164590008 | NaviCam SB Capsule - NaviCam SB Capsule is a gastrointestinal capsule endoscope used with the NaviCam SB Capsule Endoscope System to visualize the small bowel. | 855-777-0020 | info@anxrobotics.com |
| 00810164590039 | NaviCam SB Capsule/Tether - The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before releasing the NaviCam SB capsule into the stomach for a routing examination of the small bowel. | 855-777-0020 | info@anxrobotics.com |
| 00810164590114 | NaviCam Data Recorder - SB-US-2003 | 855-777-0020 | info@anxrobotics.com |
| 00810164590145 | NaviCam Locator - The NaviCam Locator is used to activate the NaviCam SB capsules and may also be used to determine if the capsule is still within the body. | 855-777-0020 | info@anxtobotics.com |
| 00810164590633 | MotiliCap GI Monitoring System Data Recorder - The MotiliCap Data Recorder is used with the MotiliCap GI Monitoring System to receive and store transmitted data from the MotiliCap capsule during the time in the GI tract. The data is then downloaded from the recorder to a computer to be analyzed by the MotiliScan software for physician analysis. | 855-777-0020 | info@anxrobotics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 237842 | 1499543621 | K250493 | MotiliCap GI Monitoring System | NYV | 2025-05-21 |
| 237842 | 1786266155 | 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 |
| 237842 | 1775512655 | K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | NEZ | 2024-01-05 |
| 237842 | 1942587578 | K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | QKZ | 2023-10-03 |
| 237842 | 1558198044 | K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | QKZ | 2023-04-13 |
| 237842 | 1773563426 | 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 |
| 237842 | 1847449762 | K221590 | NaviCam Small Bowel Capsule Endoscopy System | NEZ | 2022-12-02 |
| 237842 | 1668574504 | K203192 | NaviCam Xpress Stomach System | QKZ | 2021-05-04 |
| 237842 | 1129486182 | K201106 | IntraMarX 3D Radiopaque Marker | FFX | 2020-05-21 |
| 237842 | 1798102525 | K191087 | IntraMarX Radiopaque Markers | FFX | 2019-12-18 |
| 237842 | 2030555774 | DEN230027 | NaviCam ProScan | QZF | 2023-12-12 |
| 237842 | 1342276045 | DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | QKZ | 2020-05-22 |
Product Codes Associated With Registrations#
PMN#
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
Anx Robotica Corp
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
Anx Robotica Corporation
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
Anx Robotica Corporation
NaviCam Xpress Stomach System, NaviCam Xpress System
Anx Robotica Corp
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
AnX Robotica Corp
NaviCam Xpress Stomach System
AnX Robotica Corp
IntraMarX 3D Radiopaque Marker
AnX Robotica Corp.
IntraMarX Radiopaque Markers
AnX Robotica Corp.
GUDID#
NaviCam Data Recorder - SB-US-2003
2026-02-16
NaviCam Locator - The NaviCam Locator is used to activate the NaviCam SB capsules and may also be used to determine if the capsule is still within the body.
2026-02-16
NaviCam ESView Software - The ESView software is used with the NaviCam SB System to analyze the images and create a video for the physician to review after a capsule endoscopy procedure.
2026-02-16
NaviCam ProScan AI Software - The NaviCam ProScan AI Software is used with the NaviCam SB System with ESView to identify abnormalities of the small bowel to reduce reading time by the physician.
2026-02-16
NaviCam ESView 3.X - The NaviCam ESView 3.X software is used with the NaviCam SB System to analyze images to create a video for the physician to review after a capsule endoscopy procedure.
2026-02-16
NaviCam SB Capsule - NaviCam SB Capsule is a gastrointestinal capsule endoscope used with the NaviCam SB Capsule Endoscope System to visualize the small bowel.
2026-02-09
NaviCam SB Capsule/Tether - The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before releasing the NaviCam SB capsule into the stomach for a routing examination of the small bowel.
2026-02-09
MotiliCap GI Monitoring System Data Recorder - The MotiliCap Data Recorder is used with the MotiliCap GI Monitoring System to receive and store transmitted data from the MotiliCap capsule during the time in the GI tract. The data is then downloaded from the recorder to a computer to be analyzed by the MotiliScan software for physician analysis.
2026-02-09
MotiliCap GI Monitoring System Software (MotiliScan) - The MotilCap Software (MotiliScan) is used with the MotiliCap GI monitoring system to record and analysis GI tract transit times for the physician analysis.
2026-02-09
MotiliCap GI Monitoring System Capsule - The MotiliCap capsule is used with the MotiliCap GI Monitoring System which monitors the GI tract for temperature, pressure, and pH to help physician determine the motility of a patient.
2026-02-09
NaviCam XS Capsule - The NaviCam SB XS Capsule is used with the NaviCam SB Capsule Endoscope System to visualize the small bowel.
2026-02-09
NaviCam XS Capsule/Tether - 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.
2026-02-09
MotiliCap GI Monitoring System Mobile Phone/App - The MotiliCap Phone is used with the MotiliCap GI Monitoring System for the patient to record specified events during the procedure that will be incorporated into the final data analysis through MotiliScan.
2026-02-09
NaviCam Tether - Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. 2NaviCam Stomach Capsule and NaviCam Tether. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam System.
2023-01-05
NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System - Controller. The NaviCam Xpress Stomach System is a 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 within the stomach to be controlled by an operator
2023-01-05
NaviCam Stomach System - NaviCam Capsule Endoscope System with NaviCam Stomach Capsule; NaviCam Stomach System.
2020-12-08
NaviCam Capsule Endoscope System - 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.
2020-12-08
NaviCam Capsule Endoscope System - 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.
2020-12-08
NaviCam Capsule Endoscope System - Controller. 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.
2020-12-08
IntraMarX Radiopaque Markers - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-01-27
IntraMarX Radiopaque Markers - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-01-27
IntraMarX Radiopaque Markers - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-01-27
IntraMarX 3D - Combo
2020-12-08
IntraMarX - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-07-08
IntraMarX - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-07-08
IntraMarX - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-07-08
IntraMarX 3D - The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-07-08
IntraMarX 3D - The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-07-08
IntraMarX 3D - The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay and bowel obstruction. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-07-08
IntraMarX Radiopaque Markers - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-01-27
IntraMarX Radiopaque Markers - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-01-27
IntraMarX Radiopaque Markers - The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
2020-01-27