Industrial & Non-Medical X-Ray Apparatus

Industrial X-ray apparatus is subject to FDA performance standards for radiation-emitting electronic products under 21 CFR, and manufacturers must file an accession report with FDA before introducing such products into US commerce. These units are not subject to FDA medical device premarket clearance. Depending on the application, end-users may also need NRC or Agreement State licenses for operation.

Classification of dual-use X-ray equipment depends on the principal use or design intent of the specific imported article, not its potential alternative applications. CBP applies the General Rules of Interpretation and may consider the manufacturer's specifications, marketing materials, and any applicable CBP rulings. A binding ruling request is strongly advisable for genuinely dual-use configurations.