510(k) K251532

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) by Mighty Oak Medical — Product Code LLZ

K251532 is an FDA 510(k) premarket notification submitted by Mighty Oak Medical for the device "Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)". The FDA issued a decision of Substantially Equivalent on November 3, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Mighty Oak Medical has at least 9 other 510(k) clearances on record.