Coronary Vascular Physiologic Simulation Software

What Is It?

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

What Is FDA Product Code PJA?

Coronary Vascular Physiologic Simulation Software is FDA product code PJA, Class 2, 21 CFR 870.1415.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.