Identification. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 892.9.

Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Classification. Class II.

Image intensifier or Flouroscope, is a highly complex piece of equipment which uses x-rays and produces a 'live' image feed which is displayed on a TV screen.It allows low energy x-rays to be amplified through the machine resulting in a smaller dose to the patient. It consists of an x-ray source, input window, input phosphor, photocathode, vacuum and electron optics, output phosphor and output window. It allows for lower x-ray doses to be used on patients by magnifying the intensity produced in the output image, enabling the viewer to easily see the structure of the object being imaged. Components of Image intensifier are: C-arm (encompasses the actual X-ray source and Image intensifier), table, radiographic exposure and program controls post processing software viewing monitors. There are two types of image intensifier. They are classified into two types namely fixed image intensifier and mobile image intensifier. Fixed image intensifier are used in most x-ray departments as 'screening rooms'. The types of investigations for which this machine can be used for is vast. Examples include: barium studies, endoscopy studies (ERCP), fertility studies (HSG), angiography studies (Peripheral, Central and Cerebral), therapeutic studies. Mobile image intensifier is smaller in design than a fixed image intensifier.