Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) is an FDA 510(k)-cleared medical device (K252103) manufactured by Mighty Oak Medical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2025. Regulation: 8.