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510(k) Data Aggregation
(224 days)
ProXIma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric X-rays exams, indicated for the following:
(I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity;
(II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm;
(III) production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, where the configuration includes the CBCT option.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
The ProXIma X6 device, with its alternative proprietary names NewTom VG-One and EOS Compact is a panoramic (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system consisting of an X-ray system that acquires radiological images by rotating around the patient's head.
The X-ray device consists of a rotating arm fitted on a column support for carrying out panoramic X-rays or tomographic examinations.
The rotating arm is able to rotate and translate with motorized movements, allowing the X-ray generator and the image detector to move around the patient according to complex orbits that follow the morphological profile. The rotary arm is applied on a column support which can slide vertically through a motorized movement.
The X-ray device can feature a cephalometric examination arm, fitted on the column support. The arm houses a cephalostat, which keeps the patient position during the exam, and the image detector which translates in synchronization with the X-ray source movement.
User's choice, the X-ray device can be equipped with a single image detector (thus the operator must position it on the rotary arm for panoramic X-rays or on the cephalometric examination arm for tele-X-ray examinations - CEPH) or with two separate image detectors (which cannot be moved, one on the rotary arm and the other on the cephalometric examination arm).
The device is a digital imaging equipment created to simplify the acquisition process for X-ray image, intended for use by qualified professionals in the field, which allows to obtain dental images.
The image is acquired through the use of an X-ray detector and a constant-voltage X-ray source, powered by a high-frequency and high-voltage generator. The image is then transferred to a computer, either in real time (2D or 3D) or subsequently (2D) depending on the operator's selection and requirements.
The equipment performs tomographic examinations through the acquisition of X-ray images through a rotational sequence and the reconstruction of a three-dimensional matrix of the volume examined, producing two- and three-dimensional views of this volume. This technique is known as CBCT.
ProXIma X6 is a digital X-ray unit, suitable for professionals in the sector, allowing them to obtain dental imaging in a simple, automated manner. The image is acquired through the use of an X-ray detector and a constant-voltage X-ray source, powered by a high-frequency high-voltage generator. The image is then transferred to a computer in real time for subsequent processing.
ProXIma X6 allows the following acquisitions to be made:
- paediatric panoramic or standard views (PAN);
- complete or partial view of the teeth, selected by the user (DENT);
- frontal and lateral views of the maxillary sinus (SIN);
- lateral and posterior-anterior views of the temporomandibular joints (TMJ).
Where equipped with CEPH arm, ProXIma X6 offers the following projections:
- cephalographies in latero-lateral view, in different formats;
- cephalographies in anteroposterior and posteroanterior view;
- hand (carpus) X-ray.
If the configuration includes CBCT exams, ProXIma X6 also allows the acquisition of tomographic images.
The configuration of ProXIma X6 device X-ray system consists of the main parts listed below:
- Tomographic CBCT panel or Sensor for panoramic x-ray exams (alternatively)
- Patient head support for panoramic and CBCT acquisitions
- Arm for cephalometric x-ray exams (optional)
- Sensor for cephalometric x-ray exams (optional)
- Patient head support for cephalometric acquisitions (optional)
- Handles for patient positioning
- Laser pointers
- X-ray source
- Telescopic column (optional)
- Stands for floor support (optional)
The device must be used in conjunction with software for acquisition and management of 2D and 3D images. The software system is identified for simplicity by the name 'Neowise,' which corresponds to the name of the interface module and appears on the user interface screens. The software is installed on a general purpose Personal Computer and offers all the functions necessary to perform the exam (from movements control to X-ray acquisition), save images and patient's data, manage, process, view and share 2D and 3D images, which can be obtained either from the CEFLA device or from external sources, and provides import/export of images or reports in different standard formats.
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