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

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 23 Oct 2026.

Trade Name

LumiGuide Equipment EUDAMED

LumiGuide GUDID

Generic Name

Diagnostic x-ray digital imaging system workstation application software

Model / Ref / Catalog

722480, 722484, LumiGuide Equipment

Primary DI / UDI-DI

00884838124301, 00884838128132

Basic UDI-DI

0884838BM1700MC

510(k) Number

K252645 ↗

FDA Product Code

DQK

EMDN Code

Z11039099 Various radiodiagnostic and interventional instruments – other

GMDN Term

Diagnostic x-ray digital imaging system workstation application software

Models / Variants

LumiGuide Equipment R2.1

LumiGuide Wire

LumiGuide 3D Hub

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 870.1425

EU market of registration

Netherlands

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Azurion upgrade to R4

  Class IIb

  CE/MDR

• Marlin 1.5T

  Class IIb

  CE/MDR 2243595CE01 Active Valid to May 2030

• Zenition 30

  Class II

  FDA 510(k) K254205 Active Cleared 7 Aug 2026

• dS 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 3.0T

  Class II

  FDA 510(k) K262330 Active Cleared 30 Jul 2026

• dS FootAnkle 16Ch 1.5T

  Class II

  FDA 510(k) K262294 Active Cleared 24 Jul 2026

• Multimodality Simulation Workspace (MM Sim) Upgrade

  Class IIb

  CE/MDR GUDID on market

See all devices from Philips Medical Systems Nederland B.V. →

• What types of vascular procedures is the LumiGuide system designed to assist with, and how does it work?

  The LumiGuide system is designed for coronary and peripheral vascular interventions. It uses near-infrared fluorescence imaging to visualize and guide catheter placement within blood vessels. The LumiGuide Wire emits fluorescence when activated by compatible imaging equipment, allowing clinicians to track its position in real-time and navigate complex vessel anatomy more accurately.

• Is the LumiGuide Wire reusable, and if not, how is it supplied and prepared for use?

  The LumiGuide Wire is a single-use device, meaning it is not intended for reuse. It is supplied sterile in a ready-to-use kit, eliminating the need for additional preparation steps before use. This ensures sterility and reduces the risk of contamination during procedures.

• What equipment is required to activate and visualize the LumiGuide Wire during a procedure?

  The LumiGuide Wire requires the LumiGuide Equipment R2.1 for activation and visualization. This equipment is designed to integrate into existing catheterization labs and works in conjunction with the wire to enable near-infrared fluorescence imaging, allowing real-time tracking of the catheter within the vessel.

• How should the LumiGuide system components be stored, and are there any special handling instructions?

  The LumiGuide system components, including the LumiGuide Wire, should be stored following standard sterile medical device protocols. Since the wire is supplied sterile in a ready-to-use kit, it should remain unopened until immediately before use. The LumiGuide Equipment R2.1 and 3D Hub should also be stored according to manufacturer guidelines to maintain their functionality and sterility where applicable.

• What regulatory pathways have the LumiGuide system components undergone, and what does this mean for clinicians?

  The LumiGuide system components, including the LumiGuide Equipment R2.1, LumiGuide Wire, and LumiGuide 3D Hub, have undergone FDA 510(k) clearance and EU MDR authorization. This means the devices have been evaluated for safety and effectiveness according to regulatory standards, providing clinicians with confidence in their performance and compliance with global medical device regulations.