FDA Product Code IYN: System, Imaging, Pulsed Doppler, Ultrasonic
FDA product code IYN covers pulsed Doppler ultrasonic imaging systems.
These devices use pulsed-wave Doppler technology to measure blood flow velocity and visualize vascular structures in real time. They are widely used in cardiology, obstetrics, and vascular diagnostics.
IYN devices are Class II medical devices, regulated under 21 CFR 892.1550 and reviewed by the FDA Radiology panel.
Leading manufacturers include GE Medical Systems Ultrasound and Primary Care Diagnostics, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and Samsung Medison Co., Ltd..
List of System, Imaging, Pulsed Doppler, Ultrasonic devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Imaging, Pulsed Doppler, Ultrasonic devices (product code IYN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Radiology FDA review panel. Browse all Radiology devices →