510(k) K211247

PET VCAR by GE Medical Systems SCS — Product Code KPS

K211247 is an FDA 510(k) premarket notification submitted by GE Medical Systems SCS for the device "PET VCAR". The FDA issued a decision of Substantially Equivalent on July 27, 2021. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. GE Medical Systems SCS has at least 10 other 510(k) clearances on record.