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
1009–1032 of 1185
Cleared Jun 09, 2003
GE VIVID 7, MODEL FC0003XX
K031663
General Electric Co.
Radiology · 11d
Cleared May 30, 2003
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
K031552
Medison America, Inc.
Radiology · 11d
Cleared Apr 21, 2003
NICOLET PIONEER TC8080
K020754
Nicolet Biomedical
Radiology · 410d
Cleared Apr 17, 2003
GE LOGIQ 9 MODEL 2375600
K030934
Ge Medical Systems, Inc.
Radiology · 23d
Cleared Apr 07, 2003
TITAN HIGH RESOLUTION ULTRASOUND SYSTEM
K030949
Sonosite,Inc.
Radiology · 12d
Cleared Mar 13, 2003
BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
K030455
Philips Ultrasound, Inc.
Radiology · 30d
Cleared Feb 11, 2003
TECHNOS MP, MODEL AU6
K023255
Biosound Esaote, Inc.
Radiology · 134d
Cleared Jan 29, 2003
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
K030191
Teratech Corp.
Radiology · 8d
Cleared Jan 24, 2003
PICUS ULTRASOUND IMAGING SYSTEMS
K023512
Pie Medical
Radiology · 95d
Cleared Jan 17, 2003
ULTRASOUND SCANNER, TYPE 2400
K024236
B & K Medical A/S
Radiology · 25d
Cleared Dec 24, 2002
USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY
K022517
U-Systems, Inc.
Radiology · 147d
Cleared Dec 18, 2002
ALOKA SSD-3500 ULTRASOUND SYSTEM
K023996
Aloka Co., Ltd.
Radiology · 15d
Cleared Dec 12, 2002
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
K023957
Sonosite,Inc.
Radiology · 15d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Sep 06, 2002
SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K022858
Novasonics, Inc.
Radiology · 9d
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 Jul 02, 2002
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM
K021984
Inceptio Medical Technologies, LC
Radiology · 14d
Cleared Jun 13, 2002
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
K020630
Ultrasonix Medical Corporation
Radiology · 107d
Cleared Jun 05, 2002
U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000
K013902
U-Systems, Inc.
Radiology · 191d
Cleared May 31, 2002
SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)
K021628
Sonosite,Inc.
Radiology · 14d
Cleared Apr 25, 2002
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
K014168
Biosound Esaote, Inc.
Radiology · 127d