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FONA XDC is an intraoral dental X-ray device intended for dental radiographic examination and diagnosis of diseases related to the anatomical structures of the teeth in both adult and pediatric patients.

The device consists of an X-ray generator, a CPU that manages the exposure time and a mechanical suspension system, for wall mounting or mobile stand. The image detectors (a necessary component for a fully-functional diagnostic system) are not part of the current submission. The device, unlike the previous IntraOs 70 with AC power supply of the tube, is powered at constant potential, i.e. direct current, guaranteeing excellent quality of the final image. From an application point of view, FONA XDC radiographic system is similar to the IntraOs 70; it is possible to select nine anatomical zones (two more than in IntraOs 70), two patient body sizes and three types of receptors that can be set at different sensitivities. The basic radiographic system allows to operate at 20 cm (8") source-skin distance (SSD) with circular radiation beam. The FONA XDC primary collimator, as for the IntraOs 70, consists of a brass cylinder and the limitation of the beam on a circular surface of 6 cm in diameter from the focus for a working distance of 20 cm. It is possible to bring the working distance to 30 cm from the focus by adding a cone extension. It is also possible to reduce the exposed circular area both by working at 20 cm and at 30 cm. with the interposition of rectanqular 3x4 cm or 2x3 cm BLD adaptor, for image receptors of size 2 (adult) or size 0 (child) respectively

Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations. Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial regions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.

Stellaris 3D is a dental X-ray system for Panoramic and Cone Beam Computed Tomography (CBCT) which allows to perform all the radiographic projections, both 2D and 3D, of most interest for the dentist, the surgeon and the maxilla-facial radiologist. In addition to the functions of Panoramic and 3D radiography, Stellaris 3D Ceph also allows to perform One-Shot Cephalometric radiographs. Stellaris 2D is a dental X-ray system for Panoramic which allows to perform all the radiographic projections of most interest for the dentist, the surgeon and the maxilla-facial radiologist. In addition to the functions of Panoramic, Stellaris 2D Ceph also allows to perform One-Shot Cephalometric radiographs. Except for the panoramic acquisition sensor, the remaining mechanical, electrical and software characteristics of Stellaris 2D are exactly identical to those of Stellaris 3D. The control panel interface on the unit provides a complete control of the operation and for the setting of the desired technique factors. Class I LASER aiming lights support positioning of patient's head, which is stabilized through the use of bite blocks, chin rest, and, if required, temple supports. The user controls the exposure using a manual hand-switch, implementing the dead man functionality. An Ethernet connection cable allows the FONA Stellaris devices to interface with a computer for image acquisition, processing and storage.

Acquisition of intraoral X-Ray image of the human dental arch. In particular: • The STARX-1/ STARX PRO-1 sensors (active area 20 x 30 mm) allow to acquire the majority of intraoral images both vertically and horizontally. • The STARX-2/ STARX PRO-2 sensors (active area 26 x 34 mm) allow to acquire horizontal bitewing images.

The StarX-1, StarX-2, StarX PRO-1 and the StarX PRO-2 are digital intraoral sensors based on CMOS technology for intraoral X-Ray image acquisition of the human dental arch. The sensors are available in two sizes; in particular: • StarX-1 / StarX PRO-1 sensors: active area 20 x 30 mm • StarX-2 / StarX PRO-2 sensors: active area 26 x 34 mm The differences between the sensors are the sizes and the different kind of scintillator (Cesium lodide - Csl and Gadolinium Oxysulfide - GOS). StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 are directly connected to the acquisition PC through the USB connection. Up to three sensors can be connected to one PC at time. The type of X-ray systems that integrate with the sensors are wall-mounted Xray intraoral generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, which will control the exposure time. The sensor is supplied with an acquisition (TWAIN) module to acquire images from the sensor via the USB. The user can further process these images via a patient management software to process, filter and modify images using a software such as the Oris Win DG software which is not part of this submission. The device cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver only. Before FONA sells this device, the team discuss the hardware and software requirements of the user to make sure that their systems are compatible with the FONA sensors. FONA provides technical support for this device to ensure proper operation and to answer any questions regarding the functioning of the device. Contact details are provided to all end users and in the user manual.