510(k) K223152

Vision 2, EVARVision, TrackVision 2, HeartVision 2 by GE Medical Systems SCS — Product Code LLZ

K223152 is an FDA 510(k) premarket notification submitted by GE Medical Systems SCS for the device "Vision 2, EVARVision, TrackVision 2, HeartVision 2". The FDA issued a decision of Substantially Equivalent on November 22, 2022. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. GE Medical Systems SCS has at least 10 other 510(k) clearances on record.