510(k) K213725

CardIQ Suite by GE Medical Systems SCS — Product Code JAK

K213725 is an FDA 510(k) premarket notification submitted by GE Medical Systems SCS for the device "CardIQ Suite". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. GE Medical Systems SCS has at least 10 other 510(k) clearances on record.