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Found 4 results
510(k) Data Aggregation
K Number
K241934Device Name
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
Manufacturer
AnX Robotica Corp.
Date Cleared
2024-07-31
(29 days)
Product Code
QKZ
Regulation Number
876.1310Why did this record match?
Applicant Name (Manufacturer) :
AnX Robotica Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K230694Device Name
NaviCam Xpress Stomach System, NaviCam Xpress System
Manufacturer
AnX Robotica Corp.
Date Cleared
2023-04-13
(31 days)
Product Code
QKZ, OKZ
Regulation Number
876.1310Why did this record match?
Applicant Name (Manufacturer) :
AnX Robotica Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (>/=22 years) with BMI < 38. The system can be used in clinics and hospitals, including ER settings.
The NaviCam Tether is an accessory of the NaviCam Stomach Capsule. It is intended to aid the Capsule for visualizing the esophagus (not magnetically maneuvered) prior to the Capsule's release into the stomach capsule endoscopy (MCCE) procedure.
Device Description
The NaviCam Xpress Stomach System 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 within the stomach to be controlled by an operator.
The NaviCam Xpress Stomach System includes the following key components:
- 1. Ingestible capsule (CP-US-7005) for obtaining images.
- 2. Data recorder (MC-US-1006) for logging image data.
- 3. Locator (SB-US-2006) for turning on the capsule and for determining if the capsule is still in the body.
- 4. Controller, NaviEC-2000 (MC-US-1002) with the NaviCtrl software that allows the navigation of the capsule within the stomach.
- 5. ESView software for review of the images obtained by the capsule and generating reports.
- Optional Accessory: NaviCam Tether (ES-US-7005) for aiding the capsule in visualizing 6. the esophagus.
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K Number
K201106Device Name
IntraMarX 3D Radiopaque Marker
Manufacturer
AnX Robotica Corp.
Date Cleared
2020-05-21
(27 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
AnX Robotica Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IntraMarX 3D Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult, IntraMarX 3D Radiopaque Markers is dispensed only by physicians to patients for oral intake.
Device Description
The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many Gl conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within 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 Gl tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.
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K Number
K191087Device Name
IntraMarX Radiopaque Markers
Manufacturer
AnX Robotica Corp.
Date Cleared
2019-12-18
(238 days)
Product Code
FFX
Regulation Number
876.1725Why did this record match?
Applicant Name (Manufacturer) :
AnX Robotica Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IntraMarX Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult only, IntraMarX Radiopaque Markers is dispensed by physicians to patients for oral intake.
Device Description
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 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.
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