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LumiGuide Wire - LumiGuide Equipment R2.0

by Philips Medical Systems Nederland B.V.

510(k) K233853

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233853↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK233853 Date14 Mar 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DQK
Models / Variants
LumiGuide Equipment R2.0
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LumiGuide Wire, LumiGuide Equipment R2.0, and LumiGuide 3D Hub are intravascular imaging and guidance systems designed for real-time visualization of coronary and peripheral vessels during percutaneous coronary interventions (PCI) and other endovascular procedures. These devices utilize fluorescence imaging to enhance the identification of plaque, stenosis, and vessel anatomy, improving procedural accuracy and reducing fluoroscopy time.

The LumiGuide Wire is a single-use, reusable component of the system, while the LumiGuide Equipment R2.0 and LumiGuide 3D Hub serve as imaging and processing platforms. Supplied as a sterile or non-sterile kit depending on the component, these devices are intended for use in catheterization laboratories and interventional radiology settings. Authorized under FDA 510K and MDR compliance, they adhere to strict regulatory standards for intravascular imaging systems.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of procedures can the LumiGuide system be used for, and how does it improve outcomes?

    The LumiGuide system is designed for real-time visualization of coronary and peripheral vessels during percutaneous coronary interventions (PCI) and other endovascular procedures. It uses fluorescence imaging to help identify plaque, stenosis, and vessel anatomy, which enhances procedural accuracy and reduces the need for fluoroscopy—thereby lowering radiation exposure for both patients and staff.

  • Is the LumiGuide Wire single-use or reusable, and how does that affect its use in a catheterization lab?

    The LumiGuide Wire is explicitly labeled as a single-use component of the system, meaning it is intended for one-time use per procedure. This design choice helps ensure sterility and reduces the risk of cross-contamination between patients, which is critical in high-turnover settings like catheterization labs.

  • How are the LumiGuide Equipment R2.0 and LumiGuide 3D Hub supplied, and what role do they play in the system?

    The LumiGuide Equipment R2.0 and LumiGuide 3D Hub are supplied as kits, with sterility or non-sterility depending on the specific component. The Equipment R2.0 serves as the imaging platform, while the 3D Hub processes and displays the fluorescence-based vessel images in real time, enabling precise guidance during interventions.

  • What regulatory pathways does the LumiGuide system follow, and how does that impact its adoption?

    The LumiGuide system is authorized under both FDA 510(k) clearance and MDR compliance, meaning it meets stringent regulatory standards for intravascular imaging devices. This dual authorization supports its adoption globally, ensuring it aligns with both U.S. and European medical device regulations while maintaining high safety and performance benchmarks.