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 ArteryFlow Technology Co., Ltd., Pie Medical Imaging BV and Qfr Solutions BV.
FDA 510(k) Cleared X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device Devices (Product Code QHA)
About Product Code QHA - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QHA since 2019, with 7 receiving FDA clearance (average review time: 190 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under QHA have taken an average of 145 days to reach a decision - down from 208 days historically, suggesting improved FDA processing for this classification.
QHA devices are reviewed by the Radiology panel. Browse all Radiology devices →