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REXTAR PRO is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for adult patients.

The REXTAR PRO is an X-ray device offering a lightweight, compact portable X-ray generator. The generator is a high frequency X-ray generator, with a high Output at 70kV / 2mA. The battery-powered device is a Ripple-free HF type of generating device. The REXTAR PRO X-ray function is controlled by Touch Screen and Button for convenience. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. REXTAR PRO uses a high-quality shielding material for shielding (using domestically produced 99.9% purity lead. The RETAR PRO minimizes the exposure of the users from X-ray scattering by adding a backscatter shield. The REXTAR PRO's uses a GRID Tube and is a specialized X-ray tube that improves the quality of the x-ray beam by controlling the flow of electrons through the GRID placed between the cathode and anode. It's application of the Focal Spot 0.2mm GRID Tube for clearer, high-quality imaging helps with the diagnosis for accurate procedures and minimizes patient radiation exposure.

XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in a professional healthcare facility environment.

XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in the professional healthcare facility environment. But the image detectors (an integral part of a complete dental system) are not part of the device. The operation principle of the device involves emitting x-ray source when a high voltage is supplied to the X-ray tube assembly, which frees electrons from the cathode. They hit anode to produce X-rays. The device acquires images by emitting X-rays continuously on the human tooth. And the functions of the dental generator XERO a are supported by firmware. This is of basic firmware documentation level, and there is no external data exchange port in the device. Moreover, the XERO a is not wireless. The subject dental system is not a cyber device.

The Lucas Lifecare's Life Ray handheld is indicated for use only by a trained and qualified dentist or dental technicians for both adult and pediatric subjects for producing diagnostic dental images using various intraoral image sensors/receptors.

LifeRay™ is a battery-operated, handheld, dental X-ray device. LifeRay™ employs a 100 kHz highfrequency DC X-ray generator. This oil-cooled and shielded tube head is energized by a rechargeable lithium-ion battery pack. The battery is housed under to enable portability. The battery gets charged when the device is docked into its cradle, which is powered through an AC - DC power supply. To focus exposure on the specified zone of the subject, and limit radiation leaking elsewhere out of the device, a shielded beam-limiting cone is engaged to the tube head. This restricts the X-ray field to 60 mm diameter, compatible to dental image receptors. An additional transparent, circular backscatter shield is provided which shall be permanently mounted around the exit of the beam limiting cone to arrest radiation scattering back from the subject, so clinicians can perform in proximity. A wrist lanyard facilitates secure grip, and an inclination display aids in consistent repeatability of radiographs. LifeRay™ employs a fixed tube current of 2.6 mA, but has three selectable tube voltages: 60, 65, or 70 kVp. Exposure duration can be set between 10 ms to 1 s in steps of 10 ms. All these presets can be selected from the home screen of the display through a practical keypad to achieve the best radiograph results.

The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.

The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors.

The Handheld Dental X-ray System, model XVbeam2000, is indicated for use only by a trained and qualified dentist or dental technician as an extraoral X-ray source to produce diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The subject device Handheld Dental X-ray System, model XVbeam2000, is a battery-operated, portable extraoral X-ray source system that is designed to generate X-rays to produce diagnostic quality intraoral X-ray images utilizing intraoral image receptors. The device can be used with three receptor types: film, digital intraoral X-ray sensors, and phosphor plates. The subject device is designed for use in a dental office or similar environments (hospital ward etc.) where appropriate safeguards are implemented. The subject device XVbeam2000 is an X-ray device with a DC generator. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. This facilitates portability of the device.

The Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral dental X-ray source to produce X-ray images using intraoral image receptors.

These are hand-held portable battery operated x-ray generators for dental purposes. The Portable Dental X-Ray is an X radiation controlled emissions generator system, i.e., once put into service, is intended to be moved from one location to another by a person, used together with appropriate capture devices to generate intraoral radiological images for dental assessment, diagnosis and treatment. This equipment has exposure programs that can be applied to a variety of patients and has predefined exposure parameters depending on the type of patient. The operator is free to change these parameters depending on the situation. The equipment's human-machine interface consists of a control panel located on the top of the equipment, a local trigger button and a remote trigger (hard wired). The triggers are "dead-man" triggers, meaning they release and interrupt the exposure. The Portable Dental X-Ray was designed to be used in adult and children patients by trained dentists and dental technicians to produce X-ray images for diagnosis. The Portable Dental X-Ray is indicated for the production of intraoral medical images of teeth, mandible and oral structures; it assists in the diagnosis of diseases, planning of surgical treatment and monitoring. It is exclusively for dental use, and must be used and handled by qualified and trained health professionals according to the User Manual.

x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device. The device is operated and used by dentists, radiologists and other legally qualified health care professionals.

x-mind dc consists of the following parts: - 1 X-ray control unit (timer) - 2 Wall plate and horizontal bracket - 3 Pantograph type arm (scissor arm) - 4 X-ray source assembly (tubehead) - 5 Collimator cone (Beam Limiting Device) The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures. The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays. The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam. x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).

DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects.

DVAS, the extra-oral source x-ray system for dentistry is the standard X-ray equipment used to acquire intraoral images of patients during dental diagnosis such as dental caries, periodontal diseases, dental root fracture, and other oral and dental pathologies. DVAS is used to provide anatomic X-ray images of a patient at hospitals or dental clinics using a cone for X-ray exposure. The doctor or dentist can check the acquired X-ray images with chemical films or a PC monitor. DVAS can be used Digital I/O Sensor, Image plate (CR), Film as a Image receptor. The image receptors are not part of this submission.

N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.

N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it's not based on the predicate software.