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 Edgecare, Inc..
FDA 510(k) Cleared System, Imaging, Pulsed Echo, Ultrasonic Devices (Product Code IYO)
About Product Code IYO - Regulatory Context
510(k) Submission Activity
892 total 510(k) submissions under product code IYO since 1977, with 892 receiving FDA clearance (average review time: 129 days).
Submission volume has remained relatively stable over the observed period, with 17 submissions in the last 24 months.
FDA Review Time
Recent submissions under IYO have taken an average of 169 days to reach a decision - up from 128 days historically. Manufacturers should account for longer review timelines in current project planning.
IYO devices are reviewed by the Radiology panel. Browse all Radiology devices →