HeartNavigator Release 2.0
by Philips Medical Systems Nederland B.V.
510(k) K140138
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) | NumberK140138 | Date10 Jun 2014 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDD 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- Withdrawn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 HeartNavigator Release 2.0 is an Interventional Fluoroscopic X-Ray System, designed for real-time imaging guidance during cardiac procedures. It provides high-resolution visualisation of cardiac structures and interventions, supporting precise navigation and catheter placement within the heart.
This system is intended for use in radiology settings and is supplied as a reusable medical device. It has been authorised under FDA 510(k), MDD, and MDR regulations, with a classification as a Class II device. The device incorporates multiple FEI numbers and registration identifiers, reflecting its regulatory compliance and approved configurations for interventional procedures.
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Questions
AI-generated answers, 18 Sep 2026
What types of cardiac procedures can the HeartNavigator Release 2.0 support with its real-time imaging guidance?
The HeartNavigator Release 2.0 is designed for real-time imaging guidance during interventional cardiac procedures. Its high-resolution fluoroscopic X-ray system enables precise visualization of cardiac structures and interventions, making it suitable for procedures requiring accurate catheter placement within the heart, such as coronary angioplasty, stent placement, or structural heart interventions.
Is the HeartNavigator Release 2.0 a single-use device or can it be reused in multiple procedures?
The HeartNavigator Release 2.0 is explicitly described as a reusable medical device. This means it is intended for repeated use across multiple procedures, provided it undergoes proper maintenance, cleaning, and sterilization as per manufacturer guidelines.
What regulatory pathways has the HeartNavigator Release 2.0 followed for authorization?
The HeartNavigator Release 2.0 has been authorized under the FDA’s 510(k) pathway, as well as the European Medical Device Directives (MDD) and the Medical Device Regulation (MDR). It is classified as a Class II device, reflecting its moderate risk level and the regulatory scrutiny it has undergone.
How is the HeartNavigator Release 2.0 supplied, and what should be considered for its storage?
The device is supplied as a reusable system, meaning it is not packaged individually for single-use. Since it is reusable, proper storage conditions—such as clean, dry environments, protection from physical damage, and adherence to manufacturer maintenance protocols—are critical to ensure its longevity and performance. Specific storage instructions should be followed to maintain sterility and functionality for repeated use.
What medical specialties or clinical settings is the HeartNavigator Release 2.0 intended for?
The HeartNavigator Release 2.0 is specifically intended for use in radiology settings, particularly for interventional cardiology procedures. Its design and regulatory classification align with the needs of radiologists and cardiologists who require precise imaging guidance during cardiac interventions.