FDA.reportPublic FDA data

ANX ROBOTICA CORP.

Matched from indexed company URL: AnX Robotica Corp

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165442483016544248ANX ROBOTICA CORP.1Y2026-01-016010 W. Spring Creek Pkwy Plano TX US 75024

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810164590008NaviCam SB Capsule - NaviCam SB Capsule is a gastrointestinal capsule endoscope used with the NaviCam SB Capsule Endoscope System to visualize the small bowel.855-777-0020info@anxrobotics.com
00810164590039NaviCam 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.855-777-0020info@anxrobotics.com
00810164590114NaviCam Data Recorder - SB-US-2003855-777-0020info@anxrobotics.com
00810164590145NaviCam 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.855-777-0020info@anxtobotics.com
00810164590633MotiliCap 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.855-777-0020info@anxrobotics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2378421499543621K250493MotiliCap GI Monitoring SystemNYV2025-05-21
2378421786266155K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)QKZ2024-07-31
2378421775512655K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherNEZ2024-01-05
2378421942587578K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam TetherQKZ2023-10-03
2378421558198044K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemQKZ2023-04-13
2378421773563426K221608NaviCam 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 TetherQKZ2022-11-22
2378421847449762K221590NaviCam Small Bowel Capsule Endoscopy SystemNEZ2022-12-02
2378421668574504K203192NaviCam Xpress Stomach SystemQKZ2021-05-04
2378421129486182K201106IntraMarX 3D Radiopaque MarkerFFX2020-05-21
2378421798102525K191087IntraMarX Radiopaque MarkersFFX2019-12-18
2378422030555774DEN230027NaviCam ProScanQZF2023-12-12
2378421342276045DEN190037NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleQKZ2020-05-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QKZ62024-07-31
NEZ22024-01-05
FFX22020-05-21
NYV12025-05-21
QZF12023-12-12

PMN#

GUDID#

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.

ANX ROBOTICA CORP

2023-01-05

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

2020-01-27

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

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.

ANX ROBOTICA CORP

2020-01-27