QXZ

Adjunctive Epicardial Vascular Physiologic Status Indicator

Product code

QXZ

Device name

Adjunctive Epicardial Vascular Physiologic Status Indicator

Device class

Class 2

21 CFR

21 CFR 870.2200

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).