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
841–864 of 1185
Cleared Jun 17, 2010
OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
K093395
Olympus Medical Systems Corporation
Radiology · 230d
Cleared May 05, 2010
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K100830
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 42d
Cleared Mar 24, 2010
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
K100186
Medison Co., Ltd.
Radiology · 61d
Cleared Mar 12, 2010
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER
K092922
Sonoscape Company Limited
Radiology · 170d
Cleared Mar 05, 2010
DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR
K092907
Shantou Institute of Ultrasonic Instuments
Radiology · 164d
Cleared Mar 05, 2010
SITE-RITE VISION ULTRASOUND SYSTEM
K100402
Bard Access Systems, Inc.
Radiology · 17d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Feb 01, 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563
Philips Ultrasound, Inc.
Radiology · 75d
Cleared Jan 19, 2010
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
K093849
Medison Co., Ltd.
Radiology · 34d
Cleared Dec 23, 2009
VASCUVIEW TAP ULTRASOUND SYSTEM
K093613
Escalon Medical Corp.
Radiology · 30d
Cleared Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
K093171
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Dec 01, 2009
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
K093531
Siemens Medi Cal Solutions, Inc.
Radiology · 15d
Cleared Nov 17, 2009
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
K092271
Ge Healthcare
Radiology · 112d
Cleared Oct 09, 2009
APLIO MX SSA-780A, VERSION 1.0
K092948
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 02, 2009
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K092058
Sonosite,Inc.
Radiology · 86d
Cleared Aug 12, 2009
AIXPLORER ULTRASOUND SYSTEM
K091970
Supersonic Imagine
Radiology · 42d
Cleared Aug 06, 2009
MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
K092079
Ge Medical Systems Israel, Ultrasound, Ltd.
Radiology · 28d
Cleared Jul 29, 2009
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
K092179
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Jul 28, 2009
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K092159
Medison Co., Ltd.
Radiology · 12d
Cleared May 18, 2009
MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
K091009
Esaote, S.P.A.
Radiology · 39d
Cleared May 05, 2009
GE VENUE 40, MODEL 5324338
K091164
Ge Medical Systems China Co., Ltd.
Radiology · 13d
Cleared Apr 03, 2009
YIELD MINI DOPPLER SYSTEM
K090743
Broncus Technologies, Inc.
Radiology · 14d
Cleared Mar 31, 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114
Siemens Medical Solutions USA, Inc.
Radiology · 161d
Cleared Mar 13, 2009
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV
K090229
Chang Gung Medical Supplies & Equipment Corp.
Radiology · 42d