DEVICE: WeRay (08809840720046)

Device Description: WERAY is a battery-operated, portable dental X-ray source designed for handheld operation. It is intended to produce diagnostic-quality X-ray images. The WERAY is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow the WERAY to be used. Still, transportation or using other X-ray devices might be prohibitive due to the other devices’ size and/or lack of mobility. The WERAY is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), a Cone for the sensor, Acryl shielding, a cradle, a Hand switch for X-ray exposure, and an AC/DC adaptor. The power is supplied by a rechargeable Lithium-ion polymer battery pack built into a main body. This facilitates the portability of the device. A beam-limiting cone is incorporated within the device. The acryl shielding provides sufficient radiation protection to allow the clinician to remain in the operatory with the patient. A hand switch is available to expose X-rays in a location away from the device. WERAY uses a fixed tube voltage of 70kV and a fixed tube current of 2.0 mA to make the system as simple as possible for the operator. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel. Control buttons, a display panel, and an exposure button provide the primary operator interface. Exposure settings can be selected and displayed. The tube voltage (70 kV) and tube current (2.0 mA) are fixed, with the exposure time varying based on patient type, detector type, and anatomical features. Exposures can be completed using the exposure button. The WERAY should be used with an X-ray detector and a digital intraoral sensor. But the X-ray detector is not included in the device package.