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
865–888 of 1185
Cleared Feb 20, 2009
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K090334
Siemens Medi Cal Solutions, Inc.
Radiology · 10d
Cleared Feb 06, 2009
APLIO ARTIDA V2.0 SSH-880CV
K090158
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jan 30, 2009
MYLABFIVE
K083882
Esaote Europe B.V.
Radiology · 32d
Cleared Dec 19, 2008
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
K083254
Aloka Co., Ltd.
Radiology · 45d
Cleared Dec 12, 2008
DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K083505
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 16d
Cleared Nov 13, 2008
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K082142
Siemens Medical Solutions USA, Inc., Ultrasound DI
Radiology · 106d
Cleared Oct 31, 2008
SONIXTOUCH ULTRASOUND SYSTEM
K083095
Ultrasonix Medical Corporation
Radiology · 14d
Cleared Oct 22, 2008
M5 DIAGNOSTIC ULTRASOUND SYSTEM
K083001
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 14d
Cleared Oct 08, 2008
ZONARE ULTRA ULTRASOUND SYSTEM
K082326
Zonare Medical Systems, Inc.
Radiology · 55d
Cleared Sep 30, 2008
MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
K082656
Fukuda Denshi USA, Inc.
Radiology · 18d
Cleared Sep 25, 2008
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K081386
Esaote, S.P.A.
Radiology · 129d
Cleared Sep 02, 2008
VIVID I AND VIVID Q
K082374
Ge Medical Systems Israel, Ultrasound, Ltd.
Radiology · 15d
Cleared Aug 25, 2008
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K082098
Sonosite,Inc.
Radiology · 31d
Cleared Aug 12, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
K082119
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Aug 06, 2008
SONIX MDP ULTRASOUND SCANNER
K080935
Ultrasonix Medical Corporation
Radiology · 126d
Cleared Aug 06, 2008
GE VIVID E9 ULTRASOUND
K081921
General Electric Co.
Radiology · 30d
Cleared Jul 10, 2008
MODEL 7340 ULTRASOUND SYSTEM
K081794
Esaote, S.P.A.
Radiology · 15d
Cleared Jul 02, 2008
SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
K081676
Medison Co., Ltd.
Radiology · 15d
Cleared Jun 24, 2008
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
K081661
Philips Ultrasound, Inc.
Radiology · 11d
Cleared Jun 06, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
K081065
Toshiba America Medical Systems, In.C
Radiology · 52d
Cleared May 27, 2008
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K081320
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 15d
Cleared Apr 25, 2008
ACUSON X300 ULTRASOUND SYSTEM
K080760
Siemens Medical Solutions USA, Inc., Ultrasound DI
Radiology · 38d
Cleared Apr 07, 2008
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K080800
Medison Co., Ltd.
Radiology · 17d
Cleared Mar 27, 2008
HD7 DIAGNOSTIC ULTRASOUND SYSTEM
K080548
Phillips Medical Systems
Radiology · 28d