Cardiovascular

Coronary Artery Disease AI Notification

Flags patients whose data suggests narrowed heart arteries, for a clinician to follow up.

1 products cleared under FDA code QXX, from September 8, 2023 to September 8, 2023. Checked September 25, 2026.

Narrowed coronary arteries are common, dangerous, and frequently found late. Software in this device type looks for the pattern and raises a flag.

Only one product has cleared here so far, which tells you this is early. That is worth knowing when a vendor describes the space as established.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
QXX
FDA name for it
Coronary Artery Disease Machine Learning-Based Notification Software
Rule number
21 CFR 870.2380
Risk class
Class 2
Medical field
Cardiovascular
The FDA's own wording: Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.

Before You Sign Anything

  • Ask which inputs it needs and whether you already collect them cleanly.
  • Ask what the follow-up pathway looks like on the day a flag arrives.

Every Cleared Product, Newest First

Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.

ProductCompanyClearedFDA record
CorVista® System Corvista Health, Inc. September 8, 2023 K232686

Other Cardiovascular Device Types

Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.