FDA Product Code IYO: System, Imaging, Pulsed Echo, Ultrasonic

Under FDA product code IYO, pulsed echo ultrasonic imaging systems are cleared for general diagnostic ultrasound applications.

These systems use pulsed sound waves that reflect off tissue interfaces to generate real-time grayscale images of internal anatomy. They form the basis of B-mode (brightness mode) ultrasound used across virtually every medical specialty for anatomical visualization and procedural guidance.

IYO devices are Class II medical devices, regulated under 21 CFR 892.1560 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Quantel Medical and Volcano Corporation.