510(k) K252645

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub by Philips Medical Systems Nederland B.V. — Product Code DQK

K252645 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Philips Medical Systems Nederland B.V. has at least 10 other 510(k) clearances on record.