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..

1178
Total
1178
Cleared
94d
Avg days
1978
Since
1178 devices
697–720 of 1178
Cleared Oct 21, 2003
GE LOGIQ 5 PRO OR EXPERT
K032974
General Electric Co.
Radiology · 27d
Cleared Oct 16, 2003
SONOLINE ANTARES WITH CLARIFY VE
K033196
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 10, 2003
GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM
K032620
General Electric Co.
Radiology · 45d
Cleared Aug 22, 2003
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K032503
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Aug 06, 2003
SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K032281
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Jul 25, 2003
GE LOGIQ 7, MODEL 2354858
K032182
General Electric Co.
Radiology · 8d
Cleared Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Jul 18, 2003
ACUSON CV70 CARDIOVASCULAR SYSTEM
K032111
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared Jun 09, 2003
GE VIVID 7, MODEL FC0003XX
K031663
General Electric Co.
Radiology · 11d
Cleared Apr 17, 2003
GE LOGIQ 9 MODEL 2375600
K030934
Ge Medical Systems, Inc.
Radiology · 23d
Cleared Mar 13, 2003
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
K030455
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Dec 18, 2002
ALOKA SSD-3500 ULTRASOUND SYSTEM
K023996
Aloka Co., Ltd.
Radiology · 15d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Aug 13, 2002
SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
K022567
Acuson Corp.
Radiology · 11d
Cleared Aug 06, 2002
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K022400
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jul 30, 2002
PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER
K022303
Philips Ultrasound, Inc.
Radiology · 14d
Cleared Jul 09, 2002
CYPRESS ULTRASOUND SYSTEM
K021497
Acuson Corp.
Radiology · 61d
Cleared Apr 04, 2002
GE VIVID 3 EXPERT
K020789
General Electric Co.
Radiology · 24d
Cleared Feb 06, 2002
LOGIQ 3
K020263
General Electric Co.
Radiology · 12d
Cleared Jan 10, 2002
GE LOGIQ 5
K014097
GE Medical Systems
Radiology · 29d
Cleared Jan 07, 2002
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
K014191
Philips Medical Systems
Radiology · 17d
Cleared Aug 29, 2001
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
K012080
Aloka Co., Ltd.
Radiology · 57d
Cleared May 23, 2001
ALOKA SSD-5500 WITH KI AND A-SMA
K011457
Aloka Co., Ltd.
Radiology · 12d
Cleared May 18, 2001
GE LOGIQ 9, MODEL 2188900-X
K011188
GE Medical Systems
Radiology · 30d