510(k) K253831

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT by Cercare Medical A/S — Product Code LLZ

K253831 is an FDA 510(k) premarket notification submitted by Cercare Medical A/S for the device "CMN Capillary Function with Virtual Expert for MRI, CT and CBCT". The FDA issued a decision of Substantially Equivalent on May 18, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Cercare Medical A/S has at least 3 other 510(k) clearances on record.