DeviceClearance

Product code QHA— Radiology

AccuFFRangio

Classification name
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Device class
Class 2
Regulation
21 CFR 892.1600
Advisory panel
Radiology
Total cleared
7
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QHA under 21 CFR 892.1600, via openFDA

Market context for product code QHA

FDA has cleared 7 devices under product code QHA between 2019 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QHA

Recent clearances under product code QHA

Data sourced from openFDA. This site is unofficial and independent of the FDA.