SubtleMR (2.3.x)

SubtleMR (2.3.x) is an FDA 510(k)-cleared medical device (K223623) manufactured by Subtle Medical, 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 May 10, 2023. Regulation: 8.