510(k) K180916

iNtuition-T1 Mapping and T2/T2* Mapping by Terarecon,Inc. — Product Code LLZ

K180916 is an FDA 510(k) premarket notification submitted by Terarecon,Inc. for the device "iNtuition-T1 Mapping and T2/T2* Mapping". The FDA issued a decision of Substantially Equivalent on September 24, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Terarecon,Inc. has at least 10 other 510(k) clearances on record.