FDA Product Code QHA: X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Is A Prescription Device That Provides An Image Analysis Tool To Assess Blood Flow In The Coronary Vascular System Using X-ray Angiographic Imaging Data. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Solves Algorithms And Yields Simulation-based Metrics For Certain Cardiology Applications. X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Cannot Be Used Alone For Clinical Decision Making And Clinical Management, And Is A Tool Intended To Generate Results For Use And Review By A Qualified Clinician.
Leading manufacturers include Pie Medical Imaging BV.
List of X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device devices (product code QHA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →