X-ray apparatus—spanning diagnostic radiography systems, fluoroscopy units, and radiotherapy equipment—sits at the intersection of medical device regulation and trade classification. FDA's Center for Devices and Radiological Health (CDRH) requires premarket clearance or approval for medical-use equipment, and radiation-emitting products must comply with performance standards under the Electronic Product Radiation Control provisions. Industrial and security-screening variants of X-ray apparatus fall under the same SITC heading but face different regulatory pathways than clinical units, making end-use documentation critical at entry. Importers should confirm whether equipment qualifies as a Class II or Class III medical device before shipment.

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