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The ImaSight 4600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The ImaSight 4600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. The ImaSight 4600 is not intended for mammography.

The ImaSight 4600 is a digital radiographic sensor which automatically collects x-ray images from an x-ray source. The ImaSight 4600 sensor collects x-rays and converts them into a computer images for display on a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor comes with an acquisition box and a computer, which holds the display and processing software.