SubtleHD-PET (1.x)

SubtleHD-PET (1.x) is an FDA 510(k)-cleared medical device (K254013) 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 13, 2026. Regulation: 8.