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 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
1170 devices
169–192 of 1170
Cleared Mar 31, 2023
SonoAir Series Digital Color Doppler Ultrasound System
K223570
CHISON Medical Technologies Co., Ltd.
Radiology · 122d
Cleared Feb 16, 2023
Vivid S60N, Vivid S70N
K223832
Ge Medical System Ultrasound and Primary Care Diagnostics
Radiology · 56d
Cleared Feb 15, 2023
Versana Essential
K223407
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology · 98d
Cleared Feb 13, 2023
V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
K223387
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Feb 13, 2023
ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
K230207
Siemens Medical Solutions USA, Inc.
Radiology · 19d
Cleared Feb 10, 2023
S90 Exp Series Digital Color Doppler Ultrasound System
K222596
Sonoscape Medical Corp.
Radiology · 168d
Cleared Feb 07, 2023
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System
K222928
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 134d
Cleared Feb 06, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
K223735
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Dec 21, 2022
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
K221911
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 174d
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