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510(k) Data Aggregation

    K Number
    K241713
    Device Name
    HiRise (1040-230)
    Manufacturer
    Date Cleared
    2024-07-12

    (28 days)

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

    CurveBeam LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. The device is to be operated in a professional healthcare environment by qualified health care professionals only.
    Device Description
    The HiRise is a Cone Beam Computed Tomography Imaging Device that acquires 360-degree rotational projection sequences which are reconstructed into 3D volumetric images of the examined anatomical region. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry. The gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For non-weight bearing scans of the lower extremity, a patient positioner accessory allows the patient to sit into a position where he/she can comfortably place his/her anatomy into the imaging bore. The gantry assembly is mounted on vertical actuators and can travel vertically to capture weight-bearing anatomy at various heights ranging from the feet to the pelvis regions. The HiRise provides total vertical travel of 37 inches to accommodate patients of various sizes. Images produced by the HiRise can be sent electronically to a DICOM complaint image viewing software.
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