510(k) K191309

syngo.via MI Workflows VB40A, Scenium by Siemens Medical Soultions USA, Inc. — Product Code LLZ

K191309 is an FDA 510(k) premarket notification submitted by Siemens Medical Soultions USA, Inc. for the device "syngo.via MI Workflows VB40A, Scenium". The FDA issued a decision of Substantially Equivalent on July 19, 2019. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Siemens Medical Soultions USA, Inc. has at least 2 other 510(k) clearances on record.