21 CFR 892.1680
§ 892.1680 Stationary x-ray system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 892.1680, § 892.1680 Stationary x-ray system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91291
- Permanent ID
ys:prov:91291@1- SHA-256
ea06b2ca8115e992a57089fc22cc211392215668a91082ace3c892750695236e
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.