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
Nov 14, 2013K132527DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
Nov 8, 2013K132913VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
GE Healthcare
IYN
Nov 4, 2013K133134X-PORTE ULTRASOUND SYSTEM
FUJIFILM Sonosite, Inc.
IYN
Oct 25, 2013K132059DIAGNOSTIC ULTRASOUND SYSTEM
Advanced Instrumentations, Inc.
IYN
Oct 24, 2013K132804ACUSON S1000 / S2000 / S3000
Siemens Medical Solutions USA, Inc. Ultrasound Gro
IYN
Oct 17, 2013K132942SITE-RITE VISION II ULTRASOUND SYSTEM
C.R. Bard, Inc.
IYN
Oct 11, 2013K130881ACUSON S2000 AND S3000
Siemens Medical Solutions USA, Inc.
IYN
Oct 4, 2013K132861UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Oct 4, 2013K132768S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
Sep 24, 2013K132274AIXPLORER
Supersonic Imagine, FR
IYN
Sep 24, 2013K132171AIXPLORER
Supersonic Imagine, FR
IYN
Sep 24, 2013K131937VOLUSON I/E
GE Healthcare
IYN
Aug 28, 2013K131507XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM
Toshibamedical Systems Corporation
IYN
Aug 26, 2013K131527LOGIQ S8
GE Healthcare
IYN
Aug 21, 2013K132304EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Aug 15, 2013K132341DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Aug 1, 2013K131305CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
Chison Medical Imaging Co., Ltd.
IYN
Jul 12, 2013K131514GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
Ge Vingmed Ultrasound AS
IYN
Jun 21, 2013K131213DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
Jun 21, 2013K130833DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
IYN
Jun 19, 2013K131267VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
GE Healthcare
IYN
Jun 19, 2013K130695Z5 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jun 18, 2013K130499IU22 DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Jun 14, 2013K130801DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
Jun 6, 2013K130739ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
Siemens Medical Solutions USA, Inc.
IYN
May 24, 2013K131209TERASON USMART3200T ULTRASOUND SYSTEM
Teratech Corp.
IYN
May 24, 2013K131088PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
Apr 12, 2013K130803UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
Samsung Medison Co., Ltd., KR
IYN
Apr 12, 2013K130119PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Sonoscape Company Limited, CN
IYN
Apr 12, 2013K122537PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
IYN
Apr 5, 2013K130308NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM
Hitachi Aloka Medical, Ltd.
IYN
Apr 3, 2013K130659SPEQRT ULTRASOUND SYSTEM
Signostics Pty, Ltd., AU
IYN
Mar 25, 2013K130754ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medi Cal Solutions, Inc.
IYN
Mar 25, 2013K130173SONOSITE MAXX SERIES ULTRASOUND SYSTEM
FUJIFILM Sonosite, Inc.
IYN
Mar 21, 2013K130619ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Feb 22, 2013K130058ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
Olympus Medical Systems Corp.
IYN
Feb 15, 2013K122710TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
Shenzhen Delicate Electronics Co., Ltd., CN
IYN
Feb 13, 2013K123254ULTRASOUND SCANNER FLEX FOCUS
B-K Medical Aps, DK
IYN
Feb 8, 2013K123249DIAGNOSTIC ULTRASOUND SYSTEM
Edan Instruments, Inc., CN
IYN
Feb 6, 2013K123992APLIO 500/400/300 V3.0
Toshibamedical Systems Corporation
IYN
Feb 1, 2013K123610E-CUBE 15
Alpinion Medical Systems Co., Ltd., KR
IYN
Jan 18, 2013K123828PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
Hitachi Aloka Medical, Ltd.
IYN
Dec 21, 2012K123754CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
Philips Ultrasound, Inc.
IYN
Dec 21, 2012K123611E-CUBE 7
Alpinion Medical Systems Co., Ltd., KR
IYN
Dec 18, 2012K123564LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
GE Healthcare
IYN
Dec 13, 2012K123565PRESTO 1000 SYSTEM
Physiosonics, Inc.
IYN
Dec 13, 2012K123503DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Dec 5, 2012K123622ACUSON
Siemens Medical Solutions USA, Inc.
IYN
Oct 26, 2012K123001ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
Siemens Medical Solutions USA, Inc.
IYN
Oct 16, 2012K121564ENDOSCOPIC ULTRASOUND CENTER EU-Y0006
Olympus Medical Systems Corp.
IYN

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