Cornaris Intravascular Imaging System - LumenCross Imaging Catheter (F2)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242098 FDA 510(k)
- FDA Product Code
- NQQ FDA 510(k)
- Models / Variants
- LumenCross Imaging Catheter (F2) FDA 510(k)EUDAMED
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cornaris Intravascular Imaging System is an optical coherence tomography (OCT) imaging device designed for intravascular visualization. It provides high-resolution cross-sectional imaging of blood vessels, enabling detailed assessment of coronary and peripheral arteries. The system includes both fixed (P80-E) and portable (Mobile-E) configurations, alongside the LumenCross Imaging Catheter (F2) for catheter-based imaging.
The device is used in radiology settings for diagnostic purposes, offering real-time imaging with ≤15µm resolution and a frame rate of 200 frames per second. Supplied as a reusable system with single-use catheters, it is classified under FDA 510(k) and MDD regulatory frameworks. The P80-E and Mobile-E systems share identical software functionality, and the system supports zero-contrast agent examinations. Authorized under K242098, it adheres to product code NQQ and regulation 892.1560.
Frequently asked questions
What are the key differences between the fixed (P80-E) and portable (Mobile-E) configurations of the Cornaris Intravascular Imaging System?
The Cornaris Intravascular Imaging System offers two configurations: the P80-E, designed for fixed radiology settings, and the Mobile-E, which is portable for use in various clinical environments. Both configurations share identical software functionality and provide high-resolution optical coherence tomography (OCT) imaging with ≤15µm resolution and a frame rate of 200 frames per second. The primary difference lies in their physical setup—one is stationary, while the other is mobile—allowing flexibility depending on the clinical workflow or space constraints.
Are the catheters used with the Cornaris system single-use or reusable, and how should they be handled?
The LumenCross Imaging Catheter (F2) for the Cornaris system is designed as a single-use device. This ensures patient safety and sterility, as each catheter is intended for one-time use only. After use, the catheter should be disposed of according to standard medical waste protocols to prevent cross-contamination and maintain regulatory compliance.
What types of blood vessels can the Cornaris Intravascular Imaging System visualize, and what makes its imaging capabilities unique?
The Cornaris Intravascular Imaging System is specifically designed for detailed visualization of coronary and peripheral arteries. Its unique capabilities include high-resolution cross-sectional imaging with ≤15µm resolution and a rapid frame rate of 200 frames per second, enabling real-time assessment of vessel structures. Additionally, the system supports zero-contrast agent examinations, reducing procedural complexity and potential risks for patients.
How should the Cornaris Intravascular Imaging System be stored, and are there any specific environmental requirements?
The Cornaris Intravascular Imaging System, being a reusable device, should be stored in a clean, dry environment protected from dust, moisture, and extreme temperatures. The manufacturer’s guidelines (not provided here) should be followed for specific storage instructions, but generally, the system should be kept in its original packaging or designated storage case when not in use. The portable Mobile-E configuration may require additional considerations for transport, such as secure handling to prevent damage.
What regulatory frameworks apply to the Cornaris Intravascular Imaging System, and how does this affect its use in clinical settings?
The Cornaris Intravascular Imaging System is authorized under both the FDA’s 510(k) pathway and the European Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device in the U.S. and compliance with EU safety and performance standards. Clinically, this ensures the system meets established benchmarks for safety and effectiveness in intravascular imaging, allowing its use in radiology settings for diagnostic purposes as intended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular ..., Multimodal OCT Imaging System: P80/P80-E - vivolight.com, Portable OCT Imaging System: Mobile/Mobile-E - vivolight.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242098 | Class II | Active |
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Manufacturer
Sources (2)
- FDA 510(k) K242098 24 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 18, 2026