MRI Systems: buying guides & advice

How to Choose an MRI System

MRI systems are Class II diagnostic imaging devices that use superconducting magnets (typically 0.55T–3T for clinical use, up to 7T for research) and RF coils to produce cross-sectional anatomical images. Buyers include hospitals, imaging centers, ASCs, academic medical centers, and increasingly outpatient/rural clinics enabled by compact low-field systems. The FDA takes a risk-based approach to medical device regulation, and MRI scanners are Class II (moderate risk) medical devices, meaning that an MRI manufacturer is required to submit a 510(k) notification prior to marketing their MRI System.