DeviceClearance

Product code QEK— Cardiovascular

FFRangio

Classification name
Angiographic Coronary Vascular Physiologic Simulation Software
Device class
Class 2
Regulation
21 CFR 870.1415
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QEK under 21 CFR 870.1415, via openFDA

Market context for product code QEK

FDA has cleared 2 devices under product code QEK between 2018 and 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QEK

Recent clearances under product code QEK

Data sourced from openFDA. This site is unofficial and independent of the FDA.