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FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

HeartFlow Analysis

HeartFlow, Inc.
510k10/14/2022

HeartFlow Analysis is a software medical device that uses AI to analyze coronary CT angiography images. It provides detailed anatomical and physiological information about the coronary arteries, helping clinicians assess the risk and severity of coronary artery disease, aiding in treatment planning and diagnosis.

FDA #
K213857
Product Code
PJA
Modality:CTTask:ClassificationBody Region:Cardiac

HeartFlow FFRct Analysis

HeartFlow, Inc.
510k8/15/2019

HeartFlow FFRct Analysis is a software tool that uses AI to analyze previously acquired coronary CT images (CT DICOM data). It creates a 3D computer model of the coronary arteries and simulates blood flow and pressure to help clinicians evaluate coronary artery disease. This aids in diagnosis and treatment planning by providing functional insights beyond traditional imaging.

FDA #
K190925
Product Code
PJA
Modality:CTTask:ClassificationBody Region:Cardiac
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