21 C.F.R. § 892.1630
Electrostatic x-ray imaging system.
Cite as 21 C.F.R. § 892.1630 (2026)
(a)
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.
(b)
Classification.
Class II.