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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 unit is intended to produce panoramic or cephalometric digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by physicians, dentists, and x-ray technicians.

The device is an advanced 2-in-1 digital X-ray imaging system that incorporates PANO and CEPH (Optional) imaging capabilities into a single system and acquires 2D diagnostic image data in conventional panoramic and cephalometric modes. The device is not intended for CBCT imaging. VistaPano S is identified as panoramic-only models for VistaPano S Ceph. ProVecta S-Pan Ceph and ProVecta S-Pan are alternative model for VistaPano S Ceph and VistaPano S respectively. The subject device has different model names designated for different US distributors: - -VistaPano S Ceph, VistaPano S: DÜRR DENTAL - ProVecta S-Pan Ceph, ProVecta S-Pan: AIR TECHNIQUES । Key components of the device - 1) VistaPano S Ceph 2.0 (Model: VistaPano S Ceph), VistaPano S 2.0 (Model: VistaPano S) digital x-ray equipment (Alternate: ProVecta S-Pan Ceph 2.0 (Model: ProVecta S-Pan Ceph), ProVecta S-Pan 2.0 (Model: ProVecta S-Pan)) - 2) SSXI detector: Xmaru1501CF-PLUS, Xmaru2602CF - 3) X-ray generator - 4) PC system - 5) Imaging software

X Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

X Sensor is a digital intraoral sensor which acquires digital intra-oral images. X Sensor acquires intra oral images with a sensor that is connected to a computer to produce an image almost instantaneously following exposure. The primary advantage of direct sensor systems is the speed with which images are acquired. X Sensor includes the firmware for the sensor and the previously cleared imaging software "ExDent-I".

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 DUO Sensors are USB driven intraoral sensors which are intended to acquire intraoral radiographic images. The DUO Sensors shall be operated by trained healthcare professionals, who are educated and competent to perform the acquisition of intraoral radiographs. The DUO Sensors can be used either in combination with special positioning devices to facilitate positioning and alignment with the X-ray beam or they may also be positioned by hand with the assistance of the patient. The DUO sensors are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. DUO sensors can be used by trained dental professionals for patients receiving intraoral X-ray examinations and procedures for capturing digital X-ray images. Captured digital X-ray images can be used for examinations and diagnostic purposes with the help of optional image analysis software. The optional image analysis software is not part of this submission. DUO sensors can be used with dental positioning devices and holders to assist with aligning an X-ray source beam with the sensor and anatomy.

The DUO sensors are USB-driven digital X-ray sensors designed for health care professionals who are already acquainted with the standard procedures for acquiring dental intraoral radiographs. Digital X-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgment, and experience. The DUO Sensors are indirect converting X-ray detectors. A scintillating material converts the incident Xrays into visible light, this light is coupled optically to a CMOS technology light detection imager, and then converted to digital data. The design of the sensor assembly supports the automatic detection of incident X-rays to generate digital images for intraoral applications, once armed via a software command. The digital image created is immediately visible on the screen of a personal computer connected to the DUO sensor through the standard USB port. For DUO sensors to be used in a dental practice, an optional image analysis software will be necessary. Image analysis software is not part of the submission. DUO captured X-ray images are suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. The DUO sensors support USB2.0 connectivity to computers using a dedicated electronic assembly and a sensor software driver. Functions of the DUO sensors are controlled by software drivers and utilities support sensor activation and settings. The DUO sensors are manufactured with the same device firmware as the predicate device, Brasseler GEM.

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 RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.

RAYSCAN α-Expert (RAYSCAN α-P, SC, OCL, OCS) provides panoramic for scanning teeth, jaw and oral structures. By rotating the C-arm, which houses a high-voltage generator, an all-in-one Xray tube and a detector on each end, panoramic images of oral and maxillofacial structures are obtained byrecombining data scanned from different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a Cephalometric scanning option for obtaining Cephalic images.

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.