X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
QHA · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1600
Classification
FDA Product Code
QHA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.1600
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.