510(k) K233749

Revolution Ascend Sliding by Ge Hangwei Medical Systems Co., Ltd. — Product Code JAK

K233749 is an FDA 510(k) premarket notification submitted by Ge Hangwei Medical Systems Co., Ltd. for the device "Revolution Ascend Sliding". The FDA issued a decision of Substantially Equivalent on February 22, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Ge Hangwei Medical Systems Co., Ltd. has at least 9 other 510(k) clearances on record.