510(k) K223048

Medisystem Pacs by Medilab Manutencao E Sitemas Ltda — Product Code LLZ

K223048 is an FDA 510(k) premarket notification submitted by Medilab Manutencao E Sitemas Ltda for the device "Medisystem Pacs". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.