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 Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Siemens Medical Solutions USA, Inc. and Samsung Medison Co., Ltd..
1185
Total
1185
Cleared
94d
Avg days
1978
Since
Stable submission activity - 108 submissions in the last 2 years
Review times increasing: avg
128d
recently vs 91d historically
FDA 510(k) Cleared System, Imaging, Pulsed Doppler, Ultrasonic Devices (Product Code IYN)
1185 devices
Cleared
Oct 02, 2026
Voluson Expert 18
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
Radiology
115d
Cleared
Sep 25, 2026
EPIQ Inspira Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Radiology
64d
Cleared
Sep 25, 2026
EVO X30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Radiology
14d
Cleared
Sep 02, 2026
Vivid Explorer/Vivid Advanced/Vivid Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
134d
Cleared
Aug 24, 2026
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
Sonoscape Medical Corp.
Radiology
251d
Cleared
Aug 07, 2026
Venue Go
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
Radiology
79d
Cleared
Aug 04, 2026
Alturion Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Radiology
27d
Cleared
Jul 30, 2026
Handheld Ultrasound Scanner
IMGFAX CO., LTD.
Radiology
101d
Cleared
Jul 30, 2026
LOGIQ Focus
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
58d
Cleared
Jul 28, 2026
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Radiology
89d
Cleared
Jul 27, 2026
Philips EPIQ Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
Radiology
104d
Cleared
Jul 23, 2026
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
Beijing Konted Medical Technology Co.,Ltd
Radiology
113d
Cleared
Jul 23, 2026
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system
Esonic Technology (Wuhan) Co., Ltd.
Radiology
97d
Cleared
Jun 16, 2026
ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Radiology
92d
Cleared
Jun 09, 2026
ES-Series
E-Scopics
Radiology
95d
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
About Product Code IYN - Regulatory Context
510(k) Submission Activity
1185 total 510(k) submissions under product code IYN since 1978, with 1185 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 510(k) Review Time - IYN Product Code
Recent submissions under IYN have taken an average of 128 days to reach a decision - up from 91 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 →