21 C.F.R. § 892.1630

Current through October 31, 2024
Section 892.1630 - Electrostatic x-ray imaging system
(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.

21 C.F.R. §892.1630