QXZ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Adjunctive Epicardial Vascular Physiologic Status Indicator

Device class

Class II (moderate risk)

Regulation

21 CFR 870.2200

Medical specialty

Cardiovascular

FDA 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.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free