iNtuition-T1 Mapping and T2/T2* Mapping

iNtuition-T1 Mapping and T2/T2* Mapping is an FDA 510(k)-cleared medical device (K180916) manufactured by Terarecon,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 September 23, 2018. Regulation: 8.