510(k) K212321

JiveX (Model Number / Release: 5.3) by Visus Health IT GmbH — Product Code LLZ

K212321 is an FDA 510(k) premarket notification submitted by Visus Health IT GmbH for the device "JiveX (Model Number / Release: 5.3)". The FDA issued a decision of Substantially Equivalent on September 23, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Visus Health IT GmbH has at least 3 other 510(k) clearances on record.