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510(k) Data Aggregation

    K Number
    K182223
    Device Name
    Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
    Date Cleared
    2018-09-14

    (29 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Canon Medical Systems USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Optional movable gantry base unit for use with an Aquilion ONE (TSX-305A) system to support longitudinal movement and allow acquisition of images in the z-direction (z-axis). Note: When installed with the movable gantry base unit, Aquilion ONE can be used with the INFX-8000C system in the same room.
    Device Description
    The Infinix 4DCT is composed of the INFX-8000C interventional angiography system and the dynamic volume CT system, Aquilion ONE, TSX-305A/3. This combination enables patient access and efficient workflow for interventional procedures. Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, is an optional kit intended to be used in conjunction with an Aquilion ONE / INFX-8000C based IVR-CT system. This device is attached to the Aquilion ONE CT gantry to support longitudinal movement and allow image acquisition in the z-direction (Z-axis), both axial and helical. When this option is installed, the standard CT patient couch is replaced with the patient handling system utilized by the interventional x-ray system, INFX-8000C. The Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A, will be used as part of an Aquilion ONE / INFX-8000C based IVR-CT system. Please note, the intended uses and technological characteristics of the Aquilion ONE CT System and the INFX-8000C Interventional X-Ray System remain the same. There have been no modifications made to the imaging chains in these FDA cleared devices and the base system software remains the same. Since both systems will be installed in the same room and to prevent interference during use, system interlocks have been incorporated into the systems.
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