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
Cleared
Aug 05, 2020
XBit Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd.
Radiology
133d
Cleared
Jul 30, 2020
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp.
Radiology
100d
Cleared
Jul 24, 2020
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology
135d
Cleared
Jul 23, 2020
Vivid E80/ Vivid E90/ Vivid E95
Ge Medical Systems Ultrasound And
Radiology
122d
Cleared
Jul 16, 2020
Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
139d
Cleared
Jul 10, 2020
X-Cube 90
Alpinion Medical Systems Co., Ltd.
Radiology
137d
Cleared
Jul 10, 2020
X-Cube 70
Alpinion Medical Systems Co., Ltd.
Radiology
137d
Cleared
Jul 02, 2020
Terason uSmart 3200T Plus Ultrasound System
Teratech Corporation
Radiology
16d
Cleared
Jul 01, 2020
Versana Premier
Ge Medical Systems Ultrasound And
Radiology
162d
Cleared
Jun 24, 2020
ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Radiology
22d
Cleared
Jun 11, 2020
Versana Active
GE Medical Systems Ultrasound and Primary Care Diagnostics
Radiology
56d
Cleared
May 28, 2020
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology
45d
Cleared
May 26, 2020
ACUSON Juniper Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Radiology
28d
Cleared
May 21, 2020
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System
Edan Instruments, Inc.
Radiology
234d
Cleared
May 08, 2020
Sonosite PX Ultrasound System
FUJIFILM Sonosite, Inc.
Radiology
28d
Cleared
May 07, 2020
HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Radiology
51d
Cleared
May 01, 2020
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc.
Radiology
14d
Cleared
Apr 22, 2020
Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Radiology
47d
Cleared
Apr 17, 2020
LOGIQ E10
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology
86d
Cleared
Apr 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Radiology
28d
Cleared
Apr 10, 2020
ACUSON Freestyle Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
Radiology
30d
Cleared
Apr 09, 2020
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology
98d
Cleared
Apr 08, 2020
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology
49d
Cleared
Apr 07, 2020
HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Radiology
56d