510(k) K223427

Mimics Enlight CMF by Materialise NV — Product Code LLZ

K223427 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Mimics Enlight CMF". The FDA issued a decision of Substantially Equivalent on May 31, 2024. 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.