# K172307: Dynamic Coronary Roadmap 2.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Oct 24, 2017 after 85 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170130: Dynamic Coronary Roadmap, Philips Medical Systems Nederland B.V. (2017) Summary page 4.

## Indications for use
Dynamic Coronary Roadmap is intended to assist the physician during percutaneous coronary interventions in correlating the device position to the coronary vasculature, by providing a motion compensated overlay of this coronary vasculature. The FFR/iFR Roadmap feature is intended to assist the physician during percutaneous coronary interventions in relating the intravascular blood pressure measurement to its anatomical location. FFR/iFR roadmap visualizes the position of the pressure wire and the coronary artery on an X-ray image at the moment that an intravascular blood pressure measurement was performed as well as the intravascular blood pressure measurement values themselves. Dynamic Coronary Roadmap is suitable for use with the entire adult human population.

Source page: https://510kreport.com/device/K172307
Methodology: https://510kreport.com/methodology