§892.1630. Electrostatic x-ray imaging system.
21 C.F.R. § 892.1630
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification. Class II.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.