Magnetic Resonance Imaging (MRI) Apparatus

MRI systems are Class II or Class III medical devices regulated by FDA's Center for Devices and Radiological Health (CDRH). The device must have received 510(k) clearance or premarket approval before it can be commercially distributed. At entry, FDA may detain shipments for review, and the importer must be able to demonstrate the device's regulatory status. Radiation-emitting electronic products also require compliance with FDA performance standards under the Electronic Product Radiation Control provisions.

Complete MRI systems are classified under 9018130000, but separately imported components—such as radiofrequency coils, gradient subsystems, or superconducting magnet assemblies—may fall under different HTS headings depending on their essential character and function. Importers should obtain a binding ruling from CBP or work with a licensed customs broker to confirm the correct classification for each component, as misclassification can result in duty underpayment and penalties.