510(k) K251153

Aurora by Ge Medical Systems Israel — Product Code KPS

K251153 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Israel for the device "Aurora". The FDA issued a decision of Substantially Equivalent on June 12, 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 has at least 1 other 510(k) clearance on record.