510(k) K190780

syngo Application Software by Siemens Medical Solution USA, Inc. — Product Code LLZ

K190780 is an FDA 510(k) premarket notification submitted by Siemens Medical Solution USA, Inc. for the device "syngo Application Software". The FDA issued a decision of Substantially Equivalent on Sep 12, 2019. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Siemens Medical Solution USA, Inc. has 7 other 510(k) clearances on record.