510(k) K241981

Change Healthcare Stratus Imaging PACS by Change Healthcare Canada Company — Product Code LLZ

K241981 is an FDA 510(k) premarket notification submitted by Change Healthcare Canada Company for the device "Change Healthcare Stratus Imaging PACS". The FDA issued a decision of Substantially Equivalent on November 12, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Change Healthcare Canada Company has at least 2 other 510(k) clearances on record.