IYN · Class II · 21 CFR 892.1550

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
1185 devices
193–216 of 1185
Cleared Dec 07, 2022
Ultrasound System 2300
K222441
Bk Medical Aps
Radiology · 117d
Cleared Nov 11, 2022
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
K220983
Imsonic Medical China, Inc.
Radiology · 221d
Cleared Nov 09, 2022
Exo Iris (El2001)
K222198
Exo Imaging, Inc.
Radiology · 110d
Cleared Nov 09, 2022
ViewMate Multi Ultrasound System
K222754
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
Radiology · 58d
Cleared Oct 28, 2022
Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
K222191
Supersonic Imagine
Radiology · 98d
Cleared Oct 25, 2022
Leltek Ultrasound Imaging System (Model: LU700 Series)
K222365
Leltek, Inc.
Radiology · 82d
Cleared Oct 14, 2022
X-CUBE 70, X-CUBE 90
K221093
Alpinion Medical Systems Co., Ltd.
Radiology · 184d
Cleared Oct 13, 2022
Wireless Probe Type Ultrasound Scanner (Model: CProbe
K211321
Guangzhou Sonostar Technologies Co., Ltd.
Radiology · 531d
Cleared Oct 13, 2022
X-CUBE 50, X-CUBE 60
K220857
Alpinion Medical Systems Co., Ltd.
Radiology · 204d
Cleared Oct 11, 2022
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)
K220169
Bionet Co., Ltd.
Radiology · 264d
Cleared Sep 29, 2022
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
K221300
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 147d
Cleared Sep 29, 2022
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
K221496
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 129d
Cleared Sep 27, 2022
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
K222648
Philips Ultrasound, LLC
Radiology · 26d
Cleared Sep 15, 2022
P12 Elite Series Digital Color Doppler Ultrasound System
K221089
Sonoscape Medical Corp.
Radiology · 155d
Cleared Sep 13, 2022
P20 Elite Series Digital Color Doppler Ultrasound System
K221140
Sonoscape Medical Corp.
Radiology · 147d
Cleared Sep 12, 2022
KOLO Evolution XHD Series Ultrasound Diagnostic System
K221568
Kolo Medical (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Aug 22, 2022
HS40 Diagnostic Ultrasound System
K221599
Samsung Medison Co., Ltd.
Radiology · 81d
Cleared Aug 16, 2022
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
K221190
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Jul 22, 2022
Vivid E80, Vivid E90, Vivid E95
K220882
Ge Medical Systems Ultrasound And
Radiology · 119d
Cleared Jul 18, 2022
Vivid T8, Vivid T9
K221147
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 89d
Cleared Jul 18, 2022
Vivid iq
K221148
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology · 89d
Cleared Jul 15, 2022
Vivid S60N, Vivid S70N
K220619
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 134d
Cleared Jul 08, 2022
Transcranial Doppler Ultrasound System
K213009
Shenzhen Delica Medical Equipment Co., Ltd.
Radiology · 291d
Cleared Jun 29, 2022
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K220975
Samsung Medison Co., Ltd.
Radiology · 86d