510(k) K240724

SynthVISION 1.0.0 by Synthesis Health Intelligence, Inc. — Product Code LLZ

K240724 is an FDA 510(k) premarket notification submitted by Synthesis Health Intelligence, Inc. for the device "SynthVISION 1.0.0". The FDA issued a decision of Substantially Equivalent on August 8, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.