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The MobileX Portable X-ray System is a diagnostic X-ray system which is intended to be used by trained dentists and 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. Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.

MobileX Portable X-ray System of Denterprise International, Inc., is a handheld xray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country. The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors. This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The software is designed for a button operated device to be used by a user and a display window to be observed by the user. The software is for controlling the operation of the hardware according to the user operation that is required for this device. This software is new but this type of software is common for use in the handheld x-ray systems.

QuickRay HD is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure. The QuickRay HD dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.

The subject QuickRay HD are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package. The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm². QuickRay HD, Size 1 is also known as factory code S11684-12; QuickRay HD, Size 2 is also known as factory code S116845-12. The type of x-ray systems that integrate with the QuickRay HD sensor are wall-mounted xray 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, all will control the exposure time. This device and software 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. The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.

The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.

The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.