SubtleREFORMAT (1.x)

SubtleREFORMAT (1.x) is an FDA 510(k)-cleared medical device (K233699) 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 April 28, 2024. Regulation: 8.