ClearanceBrief
Panels › Radiology › Product code IYN · Class 2

System, Imaging, Pulsed Doppler, Ultrasonic

Regulation 892.1550

55510(k)s in 12 months (1,189 all time)
4recalls in 12 months (300 all time)
288recalls that name a 510(k)
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Top companies in IYN

Company510(k)sRecalls
Philips Ultrasound5293
Siemens Medical Solutions USA, Inc.7562
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.850
Samsung Medison Co., Ltd.700
GE Healthcare5215
GE Medical Systems Ultrasound and Primary Care Diagnostics620
Esaote, S.p.A.347
Alpinion Medical Systems Co., Ltd.250
FUJIFILM Sonosite, Inc.250
General Electric Co.230
Decided510(k)Device and applicantCode
Aug 29, 2007K072075MODIFICATION TO GE LOGIQ A3
General Electric Co.
IYN
Aug 17, 2007K071985GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
General Electric Co.
IYN
Jul 30, 2007K072000APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
Toshiba America Medical Systems, In.C
IYN
May 16, 2007K071036MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN
Apr 10, 2007K070813ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Mar 26, 2007K070576ACUSON X150 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Feb 8, 2007K063683OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE
Olympus Medical Systems Corporation
IYN
Jan 5, 2007K063803ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN
Jan 4, 2007K063761ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Dec 21, 2006K063518HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
Hitachi Medical Systems America, Inc.
IYN
Dec 21, 2006K063493I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0
Boston Scientific Corp
IYN
Dec 14, 2006K063580SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Dec 6, 2006K063500DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
IYN
Nov 22, 2006K063138MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Nov 22, 2006K061608MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
Hitachi Medical Corp.
IYN
Nov 3, 2006K060421SONARA; SONARA/TEK
Viasys Healthcare, Inc.
IYN
Nov 2, 2006K063130APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
Toshibamedical Systems Corporation
IYN
Sep 18, 2006K062578DIGI-LITE TCD DEVICE
Rimed , Ltd., IL
IYN
Aug 18, 2006K062247HD11 DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Aug 17, 2006K061980SIEMENS ACUSON X500 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Aug 7, 2006K061831MEDCHANNEL HTS SYSTEM
Medchannel, LLC
IYN
Aug 4, 2006K061827SONIX ULTRASOUND SCANNER
Ultrasonix Medical Corporation, CA
IYN
Jul 27, 2006K061643ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
Shimadzu Medical Systems
IYN
Jul 25, 2006K061637ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
Shimadzu Medical Systems
IYN
Jul 21, 2006K061946ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Jul 3, 2006K061525GE VIVID - I
General Electric Co.
IYN
Jun 30, 2006K061488CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM
Shantou Institute of Ultrasonic Instruments (Siui
IYN
Jun 22, 2006K061605NEMIO XG, SAA-580A
Toshiba America Medical Systems, In.C
IYN
Jun 14, 2006K061437SIGMA 5000 SERIES, IMAGIC
Kontron Medical Systems Sas
IYN
Jun 1, 2006K061129GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
General Electric Co.
IYN
May 19, 2006K060827MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100
Esaote, S.p.A.
IYN
May 16, 2006K061213SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
May 5, 2006K060112NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM
Nodecrest, LLC
IYN
May 3, 2006K060993GE LOGIQ P5 AND A5
General Electric Co.
IYN
Mar 31, 2006K060542GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
General Electric Co.
IYN
Jan 24, 2006K060087ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Jan 24, 2006K053648PIONEER TC8080, COMPANION III
Viasys Neuro Care
IYN
Jan 13, 2006K060059ALOKA SD-3500 ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Jan 3, 2006K053530SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Dec 16, 2005K053435GE VOLUSON I
General Electric Co.
IYN
Dec 16, 2005K053154MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM
Pie Medical
IYN
Dec 9, 2005K053258EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
Hitachi Medical Corp.
IYN
Nov 23, 2005K052894SONOLINE G60 S ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Nov 16, 2005K053084SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
Kontron Medical Systems Sas
IYN
Nov 16, 2005K053069SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
Sonosite,Inc.
IYN
Nov 10, 2005K052331ACUSON CYPRESS ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Oct 31, 2005K052911ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Oct 17, 2005K052805MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
Esaote, S.p.A.
IYN
Sep 22, 2005K052410ACUSON SEQUOIA ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Sep 21, 2005K052441GE LOGIQ 7 ULTRASOUND BT05
General Electric Co.
IYN

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