MRIaudio PREM System with MRIview

MRIaudio PREM System with MRIview is an FDA 510(k)-cleared medical device (K193102) manufactured by Mriaudio, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2020. Regulation: 8.