QEK

Angiographic Coronary Vascular Physiologic Simulation Software

Product code

QEK

Device name

Angiographic Coronary Vascular Physiologic Simulation Software

Device class

Class 2

21 CFR

21 CFR 870.1415

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

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