VesselNavigator Rel. 1.0
by Philips Medical Systems Nederland B.V.
510(k) K151598
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) | NumberK151598 | Date17 Aug 2015 | 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- Withdrawn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
- OWB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The VesselNavigator Release 1.0 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging during vascular procedures. It provides high-resolution visualization of blood vessels and guidewires, enabling precise navigation and intervention in radiology settings. The system integrates fluoroscopy with advanced imaging algorithms to enhance procedural accuracy and safety.
This device is supplied as a reusable medical system intended for use in clinical radiology departments. It is classified as Class II under FDA regulations and has received FDA 510K clearance and MDR authorization. The system is not single-use and requires proper maintenance, calibration, and storage in accordance with manufacturer guidelines to ensure MRI safety and operational reliability. Multiple registration numbers and FEI numbers are associated with its various configurations and applications.
Other devices from Philips Medical Systems Nederland B.V.
See all devices from Philips Medical Systems Nederland B.V. →
Questions
AI-generated answers, 18 Sep 2026
What types of vascular procedures is the VesselNavigator Rel. 1.0 designed to support in real-time imaging?
The VesselNavigator Rel. 1.0 is specifically designed for real-time imaging during vascular procedures, enabling precise visualization of blood vessels and guidewires. This system is particularly useful for interventions requiring high-resolution fluoroscopy, such as angioplasty, stent placement, or other endovascular treatments in radiology settings.
Is the VesselNavigator Rel. 1.0 a single-use device or intended for reuse in clinical settings?
The VesselNavigator Rel. 1.0 is a reusable medical system, not intended for single-use. It requires proper maintenance, calibration, and adherence to manufacturer guidelines to ensure operational reliability and MRI safety over repeated clinical use.
What regulatory pathways has the VesselNavigator Rel. 1.0 undergone, and what does this mean for its use?
The VesselNavigator Rel. 1.0 has received FDA 510K clearance and MDR authorization, confirming its compliance with regulatory standards for interventional fluoroscopic X-ray systems. This means it has been evaluated for safety and effectiveness, allowing its use in clinical radiology departments under the specified conditions outlined in the manufacturer’s instructions.
How should the VesselNavigator Rel. 1.0 be stored to maintain its functionality and safety?
The system must be stored in accordance with manufacturer guidelines to ensure MRI safety and operational reliability. This includes following specific storage protocols to prevent damage, contamination, or degradation of components, particularly since it is a reusable device.
Are there multiple configurations or models of the VesselNavigator Rel. 1.0, and how are they differentiated?
Yes, the VesselNavigator Rel. 1.0 includes multiple configurations and applications, each associated with distinct FEI (Facility Equipment Identifier) and registration numbers. These variations may correspond to different imaging capabilities, procedural specialties, or technical specifications, but all fall under the same core system design for vascular imaging.