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
Mar 3, 2010K093812ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Feb 1, 2010K093563IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
Philips Ultrasound, Inc.
IYN
Jan 19, 2010K093849ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Dec 23, 2009K093613VASCUVIEW TAP ULTRASOUND SYSTEM
Escalon Medical Corp.
IYN
Dec 4, 2009K093171VIAMO SSA-640A VERSION 1.2
Toshiba America Medical Systems, In.C
IYN
Dec 1, 2009K093531ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medi Cal Solutions, Inc.
IYN
Nov 17, 2009K092271GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
GE Healthcare
IYN
Oct 9, 2009K092948APLIO MX SSA-780A, VERSION 1.0
Toshiba America Medical Systems, In.C
IYN
Oct 2, 2009K092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
Sonosite,Inc.
IYN
Aug 12, 2009K091970AIXPLORER ULTRASOUND SYSTEM
Supersonic Imagine, FR
IYN
Aug 6, 2009K092079MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
Ge Medical Systems Israel, Ultrasound, Ltd.
IYN
Jul 29, 2009K092179APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
Toshiba America Medical Systems, In.C
IYN
Jul 28, 2009K092159ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
May 18, 2009K091009MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150
Esaote, S.p.A.
IYN
May 5, 2009K091164GE VENUE 40, MODEL 5324338
Ge Medical Systems China Co., Ltd., CN
IYN
Apr 3, 2009K090743YIELD MINI DOPPLER SYSTEM
Broncus Technologies, Inc.
IYN
Mar 31, 2009K083114ACUSON P50 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Mar 13, 2009K090229DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV
Chang Gung Medical Supplies & Equipment Corp.
IYN
Feb 20, 2009K090334ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medi Cal Solutions, Inc.
IYN
Feb 6, 2009K090158APLIO ARTIDA V2.0 SSH-880CV
Toshiba America Medical Systems, In.C
IYN
Jan 30, 2009K083882MYLABFIVE
Esaote Europe B.V.
IYN
Dec 19, 2008K083254ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Dec 12, 2008K083505DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Nov 13, 2008K082142ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN
Oct 31, 2008K083095SONIXTOUCH ULTRASOUND SYSTEM
Ultrasonix Medical Corporation, CA
IYN
Oct 22, 2008K083001M5 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 8, 2008K082326ZONARE ULTRA ULTRASOUND SYSTEM
Zonare Medical Systems, Inc.
IYN
Sep 30, 2008K082656MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
Fukuda Denshi USA, Inc.
IYN
Sep 25, 2008K081386MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
Esaote, S.p.A.
IYN
Sep 2, 2008K082374VIVID I AND VIVID Q
Ge Medical Systems Israel, Ultrasound, Ltd., IL
IYN
Aug 25, 2008K082098SONOSITE MAXX SERIES ULTRASOUND SYSTEM
Sonosite,Inc.
IYN
Aug 12, 2008K082119APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
Toshiba America Medical Systems, In.C
IYN
Aug 6, 2008K081921GE VIVID E9 ULTRASOUND
General Electric Co.
IYN
Aug 6, 2008K080935SONIX MDP ULTRASOUND SCANNER
Ultrasonix Medical Corporation, CA
IYN
Jul 10, 2008K081794MODEL 7340 ULTRASOUND SYSTEM
Esaote, S.p.A.
IYN
Jul 2, 2008K081676SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Jun 24, 2008K081661HD15 DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Jun 6, 2008K081065APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
Toshiba America Medical Systems, In.C
IYN
May 27, 2008K081320DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
IYN
Apr 25, 2008K080760ACUSON X300 ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN
Apr 7, 2008K080800ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
Medison Co., Ltd., KR
IYN
Mar 27, 2008K080548HD7 DIAGNOSTIC ULTRASOUND SYSTEM
Phillips Medical Systems
IYN
Mar 21, 2008K080640M5 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
IYN
Mar 11, 2008K073709MODIFICATION TO VIEWMATE SYSTEM
Ep Medsystems
IYN
Feb 29, 2008K080176ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
Aloka Co., Ltd.
IYN
Feb 8, 2008K080160APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
Toshiba America Medical Systems, In.C
IYN
Dec 19, 2007K073408GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
Ge Medical Systems Ultrasound and Primary Care Dia
IYN
Dec 18, 2007K073297GE LOGIQ P6
General Electric Co.
IYN
Oct 17, 2007K072365SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN
Sep 14, 2007K072090SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS
Siemens Medical Solutions USA, Inc., Ultrasound DI
IYN

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