Contrast Media, Ultrasound

Ultrasound Contrast Media are injectable agents, typically composed of gas-filled microbubbles, administered intravenously to enhance the echogenicity of blood and tissue during diagnostic ultrasound imaging, improving visualization of cardiac chambers, vascular structures, and organ perfusion. As a Class 3 device, it requires Premarket Approval (PMA) because its safety and effectiveness cannot be assured through general and special controls alone. No regulation number or specific medical specialty code is assigned, and it carries no implant or life-sustaining flags.