FDA's Center for Devices and Radiological Health (CDRH) regulates medical X-ray and CT equipment both as medical devices (requiring premarket clearance) and as radiation-emitting electronic products subject to performance standards under the Radiation Control for Health and Safety Act. CBP coordinates with FDA at the port of entry; shipments from non-registered foreign manufacturers or without required premarket authorization are subject to detention.

Yes — industrial irradiation systems using radioactive isotopes (such as cobalt-60 or cesium-137) are subject to Nuclear Regulatory Commission (NRC) or Agreement State licensing requirements for the radioactive material itself, separate from any customs entry requirements. Importers must coordinate with the NRC or the relevant Agreement State authority to ensure the source material is covered by an active license before the shipment arrives at the US border.