510(k) K253495

syngo.MR Applications (VB80) by Siemens Healthineers AG — Product Code LLZ

K253495 is an FDA 510(k) premarket notification submitted by Siemens Healthineers AG for the device "syngo.MR Applications (VB80)". The FDA issued a decision of Substantially Equivalent on November 20, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Siemens Healthineers AG has at least 6 other 510(k) clearances on record.