510(k) K253421

Perfusion Measurement Platform v1 by Quantified Imaging Limited — Product Code LLZ

K253421 is an FDA 510(k) premarket notification submitted by Quantified Imaging Limited for the device "Perfusion Measurement Platform v1". The FDA issued a decision of Substantially Equivalent on June 22, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.