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
793–816 of 1185
Cleared Sep 27, 2011
SONIX ULTRASOUND SCANNER
K112726
Ultrasonix Medical Corporation
Radiology · 7d
Cleared Sep 23, 2011
VENUE 40
K112122
Ge Healthcare
Radiology · 60d
Cleared Sep 16, 2011
S8 DIAGNOSTIC ULTRASOUND SYSTEM
K112451
Sonoscape Company Limited
Radiology · 22d
Cleared Sep 16, 2011
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K112596
Siemens Medical Solutions USA, Inc., Ultrasound DI
Radiology · 9d
Cleared Sep 01, 2011
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
K112213
Ge Healthcare
Radiology · 30d
Cleared Aug 29, 2011
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
K112339
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Jul 26, 2011
LOGIQ S8
K111582
Ge Healthcare
Radiology · 50d
Cleared Jul 22, 2011
LOGIQ E9
K110943
Ge Healthcare
Radiology · 109d
Cleared Jul 22, 2011
MYLABSEVEN, MYLABALPHA
K111302
Esaote, S.P.A.
Radiology · 74d
Cleared Jul 15, 2011
E-CUBE 9
K111864
Alpinion Medical Systems Co., Ltd.
Radiology · 15d
Cleared Jun 30, 2011
EZONO 3000
K102813
Life-Tech, Inc.
Radiology · 275d
Cleared Jun 30, 2011
ACUSON
K111674
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jun 24, 2011
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K111513
Philips Ultrasound, Inc.
Radiology · 23d
Cleared May 16, 2011
S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K110510
Sonoscape Company Limited
Radiology · 83d
Cleared May 13, 2011
ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM
K111227
Aloka Co., Ltd.
Radiology · 11d
Cleared Apr 15, 2011
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER
K110841
Shantou Institute of Ultrasonic Instruments (Siui
Radiology · 21d
Cleared Mar 18, 2011
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
K110482
Teratech Corp.
Radiology · 28d
Cleared Mar 14, 2011
UBM PLUS
K103471
Accutome, Inc.
Radiology · 110d
Cleared Mar 09, 2011
VOLUSON S6, VOLUSON S8
K103649
Ge Healthcare
Radiology · 84d
Cleared Mar 04, 2011
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO
K102642
Sonoscape Company Limited
Radiology · 172d
Cleared Feb 25, 2011
ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
K103397
Medison Co., Ltd.
Radiology · 98d
Cleared Feb 17, 2011
ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K110207
Aloka Co., Ltd.
Radiology · 23d
Cleared Feb 08, 2011
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
K101236
Ge Healthcare
Radiology · 281d
Cleared Feb 08, 2011
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
K110199
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Radiology · 15d