510(k) K233853

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub by Philips Medical Systems Nederland B.V. — Product Code DQK

K233853 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub". The FDA issued a decision of Substantially Equivalent on March 14, 2024. 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.