Search Results

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 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)