LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
by Philips Medical Systems Nederland B.V.
510(k) K233853
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK233853 | Date14 Mar 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DQK
- Models / Variants
- 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
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
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.