Name: Predicase
Price: 199 USD

K-number	K252645
Device name	LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
Applicant	Philips Medical Systems Nederland B.V.
Product code	DQK
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	870.1425

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

Everything you need for a 510(k) submission. Nothing you don't.