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
721–744 of 1178
Cleared May 15, 2001
SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5
K011315
Aloka Co., Ltd.
Radiology · 15d
Cleared May 04, 2001
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
K011224
Advanced Technology Laboratories, Inc.
Radiology · 14d
Cleared Mar 15, 2001
NEMIO
K010631
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Mar 01, 2001
LOGIQ 500
K010329
General Electric Co.
Radiology · 27d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200
K003514
Shimadzu Medical Systems
Radiology · 90d
Cleared Feb 12, 2001
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200
K003515
Shimadzu Medical Systems
Radiology · 90d
Cleared Jan 18, 2001
VIVID 7 WITH SONOPAC, MODEL FB0008XX
K003931
Ge Medical Systems, Inc.
Radiology · 29d
Cleared Dec 27, 2000
ALOKA SSD-4000
K003739
Aloka Co., Ltd.
Radiology · 23d
Cleared Oct 20, 2000
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K003125
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Aug 01, 2000
ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM
K001400
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared May 12, 2000
GE SYSTEM FIVE
K001267
Ge Medical Systems, Inc.
Radiology · 22d
Cleared Aug 24, 1999
ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
K992663
Aloka Co., Ltd.
Radiology · 15d
Cleared Aug 02, 1999
ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION
K991805
Acuson Corp.
Radiology · 68d
Cleared Jun 16, 1999
SSA-390A/POWER VISION 8000
K991858
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Feb 18, 1999
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
K990339
Hewlett-Packard Co.
Radiology · 15d
Cleared Jul 31, 1998
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000
K981397
Toshiba America Medical Systems, In.C
Radiology · 105d
Cleared Apr 24, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
K980557
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Sep 08, 1997
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM
K960527
GE Medical Systems
Radiology · 580d
Cleared Aug 15, 1997
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM
K972465
Aloka Co., Ltd.
Radiology · 45d
Cleared Jul 29, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964886
GE Medical Systems
Radiology · 235d
Cleared Apr 22, 1997
SONOS 2000, SONOS 2500 (M2406 A)
K964309
Hewlett-Packard Co.
Radiology · 175d
Cleared Apr 03, 1997
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
K963616
Aloka Co., Ltd.
Radiology · 205d
Cleared Dec 02, 1996
COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A
K963705
Toshiba America Medical Systems, In.C
Radiology · 77d
Cleared Aug 08, 1996
HP SONOS ULTRASOUND IMAGING SYSTEM
K954028
Hewlett-Packard Co.
Radiology · 346d