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
985–1008 of 1185
Cleared Jun 10, 2004
ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000
K040926
Hudson Diagnostic Imaging, LLC
Radiology · 63d
Cleared Jun 10, 2004
SSA-770A, APLIO VERSION 5.5
K041499
Toshibamedical Systems Corporation
Radiology · 3d
Cleared Jun 07, 2004
SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K041319
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Mar 31, 2004
ULTRASOUND IMAGING SYSTEM, MODEL 7300
K040596
Esaote, S.P.A.
Radiology · 23d
Cleared Feb 27, 2004
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM
K040409
Larsen & Toubro Limited
Radiology · 9d
Cleared Feb 20, 2004
GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587
K040251
Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
Radiology · 17d
Cleared Jan 28, 2004
SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS
K040060
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jan 08, 2004
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K034003
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Nov 05, 2003
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464
K033367
Sonosite,Inc.
Radiology · 15d
Cleared Oct 31, 2003
FUKUDA DENSHI MODEL FF SONIC UF-750XT
K033209
Fukuda Denshi USA, Inc.
Radiology · 28d
Cleared Oct 30, 2003
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
K032656
Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc
Radiology · 63d
Cleared Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 23, 2003
GE MARLIN ULTRASOUND
K033139
General Electric Co.
Radiology · 23d
Cleared Oct 22, 2003
GE LOGIQ BOOK
K032477
General Electric Co.
Radiology · 71d
Cleared Oct 21, 2003
GE LOGIQ 5 PRO OR EXPERT
K032974
General Electric Co.
Radiology · 27d
Cleared Oct 17, 2003
VIEWMATE ULTRASOUND IMAGING SYSTEM
K031066
Ep Medsystems
Radiology · 197d
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 Aug 06, 2003
SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM
K032329
Medison America, Inc.
Radiology · 8d
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