510(k) K243605

Aurora by Ge Medical Systems Israel, Functional Imaging — Product Code KPS

K243605 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Israel, Functional Imaging for the device "Aurora". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Ge Medical Systems Israel, Functional Imaging has at least 3 other 510(k) clearances on record.