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X-MIND prime 3D (and I-MAX 3D under trademark Owandy Radiology) is an extra-oral dental panoramic and CBCT (aka CBVT) X-ray unit to take either two dimensional (panoramic, TMJ and sinus exams) or three dimensional radiographic exams of teeth, jaw and oral structures. The models with cephalometric arm will be able to take two dimensional cranial cephalometric exams in different projections and the wrist exam (Carpus) dedicated to the evaluation of the bone growth. Two dimensional images are taken using the narrow beam technique. Three dimensional exams are taken using cone shaped X-ray beam technique; both of them are well known techniques. The device is operated and used by dentists, radiologists and other legally qualified health care professionals, i.e. Prescription Use (Part 21 CFR 801 Subpart D). The target patient population includes adults and pediatric patients from 7 years old [~27 kg (59.5 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

X-MIND prime 3D is an X-ray device for the radiographic analysis of the maxillo-facial complex. X-MIND prime 3D performs 2D Panoramic, Half-panoramic, Low dose Panoramic, Frontal dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Right, 2D Sinus and 2D TMJ, 3D Dentition with multiple available FOV centered in different areas of the maxillo-facial complex (Full Dentition, Maxillary Jaw, Mandibular Jaw, Maxillary Teeth, Mandibular Teeth), 3D Sinus, 3D TMJ, AP and LL cephalometric exams, Carpus exam. X-MIND prime 3D system can be used with the following type of patient: - . Patient population: the target patient population includes adults and pediatric patients from 7 years old [~25 kq (55 lb); 125 cm (49.2 in) standing height]. Anyway, the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians - Patient status: . - self-sufficient patient (the patient can autonomously place himself as requested by · the physician) - . non self-sufficient patient (the patient is assisted by medical personnel) - in any case the patient must be conscious, not anaesthetized and not incapacitated - . Nationality: multiple. The reason of the present submission is the introduction of a significative change on X-MIND prime 3D device (listing number D342123 and FDA clearance K180601). This significant change mostly consists in the addition of the cephalometric arm to X-MIND prime 3D.

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; - producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option. From a clinical point of view, X-MIND trium can be applied for the following medical indications: - Generic dentistry - Dental implantology - Dental surgery - Maxillo-facial surgery - Cephalometric analysis - Carpus radiology

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. The system consists of the X-MIND trium SCANNER and the OPERATOR'S WORKSTATION. The scanner includes a control panel, X-ray generator, sliding body, U-arm, detector sliding group, CBCT detector, PAN detector, TLD CASSETTE (optional), patient support, F group, and column. The workstation runs ACTEON IMAGING SUITE (AIS) + 2D diagnostic analysis and AIS 3D app for CBCT dataset display software. The device can be configured as PAN only, PAN / CBCT, PAN / CEPH, PAN / CBCT / CEPH (PAN Full), PAN / CBCT TLD version, and PAN / CBCT / CEPH TLD version. It can be wall mounted or self-standing. Main changes include the addition of a new accessory, the X-MIND trium TLD cassette, including a new model of CBCT sensor that can be used for both panoramic and CBCT examination, and the introduction of CEPH and PAN sensors with a wider admitted range of power supply value. A new movement of the cassette has been added to modify the SID, allowing for special exams for children with reduced SID. A new AUXCBCT board has been designed to support the new movement and cassette. A new functionality, the Low Dose functionality, allows for CBCT exams using Low Dose protocols as an alternative to Standard Dose protocols, ensuring a radiation dose saving of about 50%.

Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

AIS-Acteon Imaging Suite is an application software suite providing a set of tools used to meet the imaging requirements set by different types of dental facilities – from small clinics to large hospitals. It enables practitioners to process and permanently archive (in connection with patients) diagnostic images relating to intraoral, maxillofacial and ear nose throat areas. Images can be originated by: intraoral digital sensors, dental panoramic and cephalometric equipment, CBCT equipment, intraoral cameras and all the future ACTEON digital imaging devices. The devices that are intended to be used with AIS are X-MIND trium, X-MIND PRIME and Cameras, Sopix², Sopix2 ACE, PSPix, PSPix2, SOPROCare camera and SOPROLife (with SDK provided by ACTEON-SOPRO). AIS supports DICOM format, which makes the system flexible and ready to be connected to other compatible devices and applications.

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; - producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option. From a clinical point of view, X-MIND trium can be applied for the following medical indications : - Generic dentistry - Dental implantology - Dental surgery - Maxillo-facial surgery - Cephalometric analysis - Carpus radiology

X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral Xray system, which consists of: 1. Operator's workstation 2. X-MIND trium remote control and X-MIND trium light 3. X-MIND Trium medical device (Control panel, X-ray generator, Sliding body, U-arm, Detector sliding group, CBCT detector, PAN detector, Patient support, F group, Column) Cephalometric extension (CEPH arm extension, CEPH control panel, CEPH patient support, CEPH detector sliding group, CEPH secondary collimator, CEPH detector) Accessories (Temple rest, Chin rest, Sliding bite block and chin rest assembly, TMJ nose support, Calibration tray and geometric calibration phantom, Quality phantom support for Germany)