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..
FDA 510(k) Cleared System, Imaging, Pulsed Doppler, Ultrasonic Devices (Product Code IYN)
About Product Code IYN - Regulatory Context
510(k) Submission Activity
1159 total 510(k) submissions under product code IYN since 1978, with 1159 receiving FDA clearance (average review time: 94 days).
Submission volume has remained relatively stable over the observed period, with 108 submissions in the last 24 months.
FDA Review Time
Recent submissions under IYN have taken an average of 136 days to reach a decision - up from 89 days historically. Manufacturers should account for longer review timelines in current project planning.
IYN devices are reviewed by the Radiology panel. Browse all Radiology devices →