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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 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 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.

Digital image scanner of dental is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.

Digital image scanner of dental is a dental device that scans IP Imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on the screen and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size S0, S1, S2 and S3. The intraoral plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with 630-645 nm laser. The laser beam is moved across the surface of the plate by an oscillating mirror. The laser beam stimulates the top coating of the plates, which consists of X-rays sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier tube/ PMT) and transferred into an electrical output signal. This signal is digitalized and is the data for the digital X-ray image. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the screen, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.

The DEXIS sensor is a USB- driven digital sensor which is intended to acquire dental intra- oral radiographic images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and aligmment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

The DEXIS Sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Sensors support USB2.0 and USB 3.x connectivity to personal computers using a dedicated electronic assembly and a sensor software driver. The software and firmware for the subject device are similar to the software and firmware for the predicate device and both have a Moderate level of concern. The software performs only basic functions of image capture and transfer to a computer. The software does not perform any medical image manipulation such as image enhancements as these are expected to be performed in the dental viewing software(s) used in conjunction with the subject device. The subject device DEXIS sensor refers to the dental intra-oral detector. The x-ray generator (an essential component for a fullyfunctional dental x-ray system) is not part of the submission.

The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.

The Pluto0002XW Digital Wireless Intraoral X-Ray Sensor (Hereinafter referred to as Pluto0002XW) contains the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. The major function of the Pluto0002XW is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Pluto0002XW is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software. The iRay intra-oral software (iRayDR) is part of the system, it is used to acquire, enhance, analyze, view and share images from the sensor.

Dental Sensors, models Tuxdeluxe, 6100B-Size 1, and 6101B-Size 2 are 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. This device must only be used in hospital environments, clinics or dental offices by trained and qualified dental personnel, and not used in the oxygen rich environment. This device is suitable for providing dental radiography imaging for both adult and pediatric patients.

This Intraoral Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. This sensor was developed to obtain a high-quality x-ray image from the human mouth and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and transfers it to a computer through USB connection (Universal Serial Bus). The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device. Device sensor sizes: Size 1: 24.1 x 36.2 x 5.9mm Size 2: 30.5 x 42.8 x 5.7mm. The I/O sensor is compatible with the following cleared software: Xray Vision / XV Capture (XV Web) / Curve / Sota. This software must be purchased separately by the end user.

The WeSensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

The WeSensor is an intraoral digital x-ray sensor. It comprises three components: (1) an intraoral digital X-ray sensor which connects to a PC via a USB port; (2) WeSensor Software package; and (3) a sensor holder as an accessory.

EzSensor XHD 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.

EzSensor XHD is a digital intraoral sensor which acquires digital intra-oral images. EzSensor XHD 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. The ergonomic design based on human intraoral anatomy improves patient comfort. EzSensor XHD includes the software (firmware) with MODERATE level of concern.