Dynamic Coronary Roadmap 2.0
by Philips Medical Systems Nederland B.V.
510(k) K172307
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) | NumberK172307 | Date24 Oct 2017 | 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- Withdrawn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 Dynamic Coronary Roadmap 2.0 is an interventional fluoroscopic X-ray system accessory designed to provide real-time image guidance. It functions as a motion-compensated overlay to assist in coronary interventions by enhancing visualization of coronary anatomy during fluoroscopy.
This device is supplied as a software-based solution integrated with Philips interventional X-ray systems and is intended for single-use or reusable settings depending on the system configuration. It holds FDA 510(k) clearance and MDR authorization, classified under product code OWB as a Class 2 Radiology device. No specific sterility or MRI safety information is provided, and sizes are not applicable as it is a software-based overlay.
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Questions
AI-generated answers, 18 Sep 2026
What is the Dynamic Coronary Roadmap 2.0 used for in a clinical setting?
The Dynamic Coronary Roadmap 2.0 is a software-based accessory designed to enhance real-time visualization of coronary anatomy during fluoroscopy. It functions as a motion-compensated overlay, helping interventional cardiologists improve guidance and precision during coronary interventions by reducing motion artifacts and providing clearer anatomical reference points.
How is the Dynamic Coronary Roadmap 2.0 supplied and does it require sterilization?
The Dynamic Coronary Roadmap 2.0 is supplied as a software-based solution integrated with Philips interventional X-ray systems. Since it is software-only, there are no physical components requiring sterilization, and no specific sterility information is provided. Its use depends on the system configuration, which may allow for single-use or reusable settings.
Is the Dynamic Coronary Roadmap 2.0 compatible with all Philips interventional X-ray systems, or are there specific models it works with?
The Dynamic Coronary Roadmap 2.0 is designed specifically for integration with Philips interventional X-ray systems, but the exact compatibility depends on the system’s software configuration. While no specific model numbers are listed in the data, it is intended to function as an accessory within those systems, so compatibility should be verified with Philips support or documentation for your particular system.
What regulatory pathways has the Dynamic Coronary Roadmap 2.0 followed, and what classification does it hold?
The Dynamic Coronary Roadmap 2.0 holds FDA 510(k) clearance and MDR authorization. It is classified as a Class 2 Radiology device under product code OWB, indicating it is considered a moderate-risk medical device requiring regulatory oversight but not as stringent as higher-risk categories.
Does the Dynamic Coronary Roadmap 2.0 require any special storage conditions, and is it reusable?
Since the Dynamic Coronary Roadmap 2.0 is a software-based solution, it does not require physical storage conditions like traditional medical devices. Its reuse depends on the system configuration—it can be used in either single-use or reusable settings, but this would be determined by the specific integration and operational protocols of the Philips interventional X-ray system it is paired with.