Product code QEK

Device name

Angiographic Coronary Vascular Physiologic Simulation Software

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1415

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset