510(k) K182050

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch by Siemens Medical Solutions USA, Inc. — Product Code IYE

K182050 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch". The FDA issued a decision of Substantially Equivalent on Oct 3, 2018. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.