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 Siemens Medical Solutions USA, Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd. and GE Medical Systems Ultrasound and Primary Care Diagnostics.
1170
Total
1170
Cleared
94d
Avg days
1978
Since
Stable submission activity - 109 submissions in the last 2 years
Review times increasing: avg
134d
recently vs 90d historically
FDA 510(k) Cleared System, Imaging, Pulsed Doppler, Ultrasonic Devices (Product Code IYN)
1170 devices
Cleared
May 27, 2026
EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Radiology
132d
Cleared
May 27, 2026
EPIQ Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
Radiology
86d
Cleared
May 26, 2026
LOGIQ e
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
109d
Cleared
May 22, 2026
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
CHISON Medical Technologies Co., Ltd.
Radiology
163d
Cleared
May 21, 2026
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Wuhan United Imaging Healthcare Co.,Ltd
Radiology
178d
Cleared
May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super
Wuhan United Imaging Healthcare Co.,Ltd
Radiology
172d
Cleared
May 15, 2026
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)
Sonoscape Medical Corp.
Radiology
150d
Cleared
May 14, 2026
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
Mytech Intelligence (Shenzhen) Co., Ltd.
Radiology
120d
Cleared
May 11, 2026
Diagnostic Ultrasound System (MU9)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology
56d
Cleared
May 05, 2026
Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Radiology
265d
Cleared
May 05, 2026
Healium Intelliscan LX192LC
Healium Intelliscan Corporation
Radiology
29d
Cleared
Apr 29, 2026
ES-Series
E-Scopics
Radiology
68d
Cleared
Apr 06, 2026
6450 Ultrasound System (MyLabE80)
Esaote, S.P.A.
Radiology
189d
Cleared
Apr 02, 2026
Wireless Probe Type Ultrasound Scanner
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
Radiology
218d
Cleared
Mar 27, 2026
Butterfly Gestational Age Tool
Butterfly Network, Inc.
Radiology
261d
Cleared
Mar 27, 2026
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Radiology
129d
Cleared
Mar 27, 2026
EVO Q30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Radiology
98d
Cleared
Mar 24, 2026
LOGIQ Vita
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
22d
Cleared
Mar 16, 2026
Sonio Detect (v3)
Sonio
Radiology
227d
Cleared
Mar 10, 2026
Sonosite iLOOK Ultrasound System
FUJIFILM Sonosite, Inc.
Radiology
15d
Cleared
Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology
142d
Cleared
Jan 20, 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation
Radiology
63d
Cleared
Jan 08, 2026
LOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
100d
Cleared
Jan 07, 2026
LOGIQ Fortis
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
99d
About Product Code IYN - Regulatory Context
510(k) Submission Activity
1170 total 510(k) submissions under product code IYN since 1978, with 1170 receiving FDA clearance (average review time: 94 days).
Submission volume has remained relatively stable over the observed period, with 109 submissions in the last 24 months.
FDA 510(k) Review Time - IYN Product Code
Recent submissions under IYN have taken an average of 134 days to reach a decision - up from 90 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 →