510(k) K251964

Mimics Thoracic Planner by Materialise NV — Product Code LLZ

K251964 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Mimics Thoracic Planner". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Materialise NV has at least 10 other 510(k) clearances on record.