CardiacUS + EU
HeartFlow FFRCT Analysis
🇺🇸HeartFlow · Coronary physiology from CT
What it does
Builds a model of the coronary arteries from a CT angiogram to estimate blood-flow significance of narrowings, producing numbers the clinician reviews.
Who it's for
Cardiac imaging and cardiology teams assessing coronary artery disease from CT.
Reported performance
No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.
Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.
FDA
PathwayDe Novo
Submission #—
Product code—
Decision dateNov 1, 2014
PanelRadiology
EU (CE)
StatusCE-marked
Risk class—
Notified body—
EMDN code—
Basic UDI-DI—
AI Act class—
Vendor
Cite this page
RadPigeon. "HeartFlow FFRCT Analysis (HeartFlow)." AI Devices registry. https://radpigeon.news/ai/device/heartflow-ffrct
Last updated Jun 29, 2026 · last verified Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.
