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510(k) Data Aggregation

    K Number
    K241934
    Device 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
    876.1310
    Why 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
    K230694
    Device 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
    876.1310
    Why 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
    K201106
    Device Name
    IntraMarX 3D Radiopaque Marker
    Manufacturer
    AnX Robotica Corp.
    Date Cleared
    2020-05-21

    (27 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why 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
    K191087
    Device Name
    IntraMarX Radiopaque Markers
    Manufacturer
    AnX Robotica Corp.
    Date Cleared
    2019-12-18

    (238 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why 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.
    Ask a Question

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