Cardiovascular

Adjunctive Coronary Physiology Indicator

Estimates how much a narrowing actually restricts blood flow, from imaging rather than from a wire in the artery.

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

Seeing a narrowed artery on a scan does not tell you whether it is starving the heart muscle. Those are different questions, and the answer decides whether a patient gets a stent.

The traditional way to answer it is to thread a pressure wire into the artery during a catheter procedure. That is invasive, costs money, and carries risk.

Software in this group estimates the same thing from imaging that already exists. The word adjunctive in the FDA name is doing real work: it supports the decision, it does not replace the measurement.

Clearances per Year

What the FDA Actually Signed Off On

FDA product code
QXZ
FDA name for it
Adjunctive Epicardial Vascular Physiologic Status Indicator
Rule number
21 CFR 870.2200
Risk class
Class 2
Medical field
Cardiovascular
The FDA's own wording: The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.

Before You Sign Anything

  • Ask how the estimate compared with invasive measurement in the validation study, including where it disagreed.
  • Ask what image quality it needs, because the answer is usually stricter than a routine scan.
  • Ask how your cath lab team wants disagreements resolved before you deploy it, not after.

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
Cleerly ISCHEMIA Cleerly, Inc. September 8, 2023 K231335

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.