510(k) K183210

Thoracic VCAR with GSI Pulmonary Perfusion by GE Medical Systems SCS — Product Code LLZ

K183210 is an FDA 510(k) premarket notification submitted by GE Medical Systems SCS for the device "Thoracic VCAR with GSI Pulmonary Perfusion". The FDA issued a decision of Substantially Equivalent on Mar 29, 2019. 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 37 other 510(k) clearances on record.