Title 21 Part 892 → Subpart B → §892.1680

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1680

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1680

e-CFR data is current as of May 27, 2020

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1680

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§892.1680   Stationary x-ray system.

(a) Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]