Angiographic Coronary Vascular Physiologic Simulation Software

FDA product code QEK · Class II (moderate risk) · 21 CFR 870.1415 · Cardiovascular

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

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K192442FFRangioQEK · Special Cathworks, Ltd.12/09/2019SE
K182149FFRangio SystemQEK · Traditional Cathworks, Ltd.12/19/2018SE