Ep Navigator Rel. 5.0
by Philips Medical Systems Nederland B.V.
510(k) K142126
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) | NumberK142126 | Date9 Dec 2014 | 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- Withdrawn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 EP Navigator Release 5.0 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging and navigation during electrophysiological (EP) procedures. It provides high-resolution fluoroscopic visualization to guide catheter placement and ablation within the heart, supporting diagnostic and therapeutic interventions in cardiac electrophysiology.
This system is supplied as software integrated with compatible imaging equipment and is intended for use in clinical settings such as cardiac catheterization labs. It is classified as a Class 2 device under FDA regulations (510(k) clearance, K142126) and the MDR framework, with no indication of single-use or reusable status. The device operates within MRI-unsafe environments and requires proper calibration and storage as per manufacturer guidelines. Authorisations include FDA_510K and MDR compliance.
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Questions
AI-generated answers, 18 Sep 2026
What clinical procedures is the EP Navigator Release 5.0 primarily used for, and how does it assist in those procedures?
The EP Navigator Release 5.0 is designed for real-time imaging during electrophysiological (EP) procedures, specifically to guide catheter placement and ablation within the heart. It provides high-resolution fluoroscopic visualization, which helps clinicians perform diagnostic and therapeutic interventions in cardiac electrophysiology, such as mapping arrhythmias and delivering precise ablation treatments.
Is the EP Navigator Release 5.0 a standalone device, or does it require integration with other equipment?
The EP Navigator Release 5.0 is supplied as software integrated with compatible imaging equipment, meaning it is not a standalone device but rather a specialized software solution that enhances existing interventional fluoroscopic X-ray systems for EP procedures.
Can the EP Navigator Release 5.0 be used in environments where MRI equipment is present, and what safety considerations apply?
No, the EP Navigator Release 5.0 is not designed for use in MRI-safe environments. It operates in MRI-unsafe settings, so strict protocols must be followed to ensure patient and staff safety when used near MRI equipment.
How is the device classified under regulatory frameworks, and what does this classification imply for its use?
The EP Navigator Release 5.0 is classified as a Class 2 device under both FDA and MDR regulations. This classification implies that it is subject to stricter regulatory oversight than lower-risk devices but does not require the same rigorous scrutiny as Class 3 devices. It has received FDA 510(k) clearance and MDR compliance, indicating it has been deemed substantially equivalent to existing devices in its category.
What storage and maintenance requirements should be followed for the EP Navigator Release 5.0?
The EP Navigator Release 5.0 requires proper calibration and storage as per the manufacturer’s guidelines, though the data does not specify exact storage conditions. Since it is not indicated as single-use or reusable, it likely requires periodic maintenance to ensure optimal performance and safety in clinical settings.