510(k) K141302

VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA) by Vital Images, Inc. — Product Code LLZ

K141302 is an FDA 510(k) premarket notification submitted by Vital Images, Inc. for the device "VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)". The FDA issued a decision of Substantially Equivalent on August 1, 2014. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Vital Images, Inc. has at least 10 other 510(k) clearances on record.