510(k) K221511

Axial3D Cloud Segmentation Service by Axial Medical Printing Limited — Product Code LLZ

K221511 is an FDA 510(k) premarket notification submitted by Axial Medical Printing Limited for the device "Axial3D Cloud Segmentation Service". The FDA issued a decision of Substantially Equivalent on June 23, 2022. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Axial Medical Printing Limited has at least 4 other 510(k) clearances on record.