21 CFR 892.1630 — System, Imaging, X-Ray, Electrostatic

Radiology (RA) · Subpart B—Diagnostic Devices · § 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 Rationale

Class II.

Product Codes