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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?
    Product Code :

    QKZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K231960
    Device Name
    NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
    Manufacturer
    AnX Robotica Corporation
    Date Cleared
    2023-10-03

    (92 days)

    Product Code
    QKZ
    Regulation Number
    876.1310
    Why did this record match?
    Product Code :

    QKZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients >= 6 years old with BMI =< 65 and a waist circumference =< 77 inches. 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
    NaviCam® Xpress Stomach Capsule Endoscope System enables the operator to control the capsule endoscope inside the stomach. The capsule endoscope can be moved in any direction during examination. The direction and angulation of the capsule camera head can be adjusted in real-time, hence realizing complete control of capsule endoscope movement and attitude during examination in the X left and right, Y forward and backward, Z up and down directions as well as rotation clockwise and counterclockwise.
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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?
    Product Code :

    QKZ

    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
    K221608
    Device Name
    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
    Manufacturer
    AnX Robotica Corp
    Date Cleared
    2022-11-22

    (172 days)

    Product Code
    QKZ
    Regulation Number
    876.1310
    Why did this record match?
    Product Code :

    QKZ

    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 Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope 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. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam Capsule Endoscope System or the NaviCam Xpress Stomach Capsule Endoscope System.
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    K Number
    K203192
    Device Name
    NaviCam Xpress Stomach System
    Manufacturer
    AnX Robotica Corp
    Date Cleared
    2021-05-04

    (188 days)

    Product Code
    QKZ
    Regulation Number
    876.1310
    Why did this record match?
    Product Code :

    QKZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NaviCam Xpress Stomach System 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.
    Device Description
    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. The NaviCam Xpress Stomach System includes the following key components: Ingestible capsule (AKEM-11SW) for obtaining images, Data recorder (AKR-1) for logging image data, Locator (AKS-1) for turning on the capsule and for determining if the capsule is still in the body, Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach, ESView software for review of the images obtained by the capsule and generating reports.
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    K Number
    DEN190037
    Device Name
    NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
    Manufacturer
    AnX Robotica, Inc.
    Date Cleared
    2020-05-22

    (283 days)

    Product Code
    QKZ, OKZ
    Regulation Number
    876.1310
    Why did this record match?
    Product Code :

    QKZ

    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 old) with a BMI less than 38. The system can be used in clinics and hospitals, including ER settings.
    Device Description
    The NaviCam Capsule Endoscopy System with NaviCam Stomach Capsule is an endoscopic capsule imaging system intended to obtain images of the stomach and duodenum. In contrast to passive capsule endoscopy systems, it uses external magnetic fields to allow the position of the capsule to be controlled by an operator. The NaviCam Capsule Endoscopy System with NaviCam Stomach Capsule consists of an ingestible capsule, a data recorder, a locator, and a controller.
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