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The HiRise is intended to be used for 3-D imaging of the upper 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.

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.

CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image displaying component allows users to manipulate the images to aid in diagnosis and treatment planning, including rotating through 3D renderings and 2D MPR slices, adjusting display settings, and making measurements. It is the User's responsibility to ensure monitor quality and ambient light conditions are consistent with the clinical application.

CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image data. CubeVue provides a list of patient scans that have been sent to the its image database through its DICOM interface or imported locally by the user can browse, search, and sort the patient list to select a patient and open his or her image data. The main screen displays a 3D rendering of the image in addition to axial, sagittal, and coronal slices. In the slices, the user can navigate through the volume by paging and rotating. The user can also adjust the window level, zoom, and pan of the 2D slices. In the 3D volume, the user can rotate the volume, cut through a plane, and change the displayed tissue density threshold and rendering style. The user can make measurements on the image including distances, angles, and density values. The user can export patient data to a file or media, with the option to anonymize patient demographic information. It supports DICOM and JPEG for image communication.

The LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions. This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs *2D Imaging not intended for pediatric use

The LineUP 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. It can also capture 2D plain X-Ray projections. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For hand and elbow scans, a patient transporter accessory allows the patient to sit and then recline into a position where he/she can comfortably place his/her anatomy into the imaging bore. The transporter can also be configured to permit a seated non-weight bearing scan of the feet. 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 knee regions. The LineUP provides total vertical travel of 17 inches to accommodate patients of various sizes. Images produced by the LineUP can be sent electronically to a DICOM complaint image viewing software.

The In Reach is intended to be used for 3-D imaging of the hand, wrist, elbow, knee, foot, and ankle regions, to visualize and assess the osseous and certain soft tissue structures, bone angles and fractures. This modality is anticipated to be applicable to pediatric* cases as well as adults*, when appropriate diagnosis of a given hand, wrist, elbow, knee, foot or ankle condition is considered necessary. * Patient parameters: 50 lbs to 400 lbs

The In Reach is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray projection sequence and reconstructs a three-dimensional volume of the examined anatomical region, comprised of a stack of slices of specified thickness. The device uses a gantry assembly, which is comprised of an Xray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. The gantry assembly is mounted on vertical rails and can travel up and down those rails depending on the anatomical region of interest and patient scanning position. The vertical travel allows placement of the field-of-view opening (bore) at the desired height depending on the extremity to be scanned. The In Reach provides total vertical travel of 23.5 inches to facilitate placement of the leg or arm extremity into the bore, one limb at a time. The In Reach provides software tools to measure distances and angles on slices and 3D renderings. Images produced by the In Reach can be printed or optical media, or sent electronically. The In Reach software also displays the selected set of reconstructed slices and 3D renderings on the workstation monitor for viewing.

The PedCAT is intended to be used for 3-D imaging of the foot & ankle region, to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. This modality is anticipated to be applicable to pediatric* cases as well as adults*, when appropriate diagnosis of a given foot condition is considered necessary.

The PedCAT is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The PedCAT can measure distances and thickness on two dimensional images. Images produced by the PedCAT can be printed or exported on magnetic and optical media. The PedCAT gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full Xray sequence by the software. The software receives the two dimensional images acquired by the detector, transforms them into three dimensional images and displays them on the workstation monitor for viewing.