Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K252645 · 2025-10-24

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2025-10-24
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K252645. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub?

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K252645.

When did LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub receive FDA 510(k) clearance?

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub received FDA 510(k) clearance on 2025-10-24, under 510(k) number K252645.

Who is the listed applicant for LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub?

The FDA product code for LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub is DQK.

Other records listing Philips Medical Systems Nederland B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254205Zenition 30K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TK262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)K253614EchoNavigator R5.0K260169AV Cardiac CT

View all 80 devices →

Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑