510(k) K250800

UroNav 4 by Philips DS North America, LLC — Product Code LLZ

K250800 is an FDA 510(k) premarket notification submitted by Philips DS North America, LLC for the device "UroNav 4". The FDA issued a decision of Substantially Equivalent on June 5, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.