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 18, 2016K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Aug 5, 2016K161706Vivid iq
Ge Medical Systems Ultrasound and Primary Care Diagnostics L
IYN
Aug 5, 2016K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Jul 28, 2016K161787ACUSON NX2 Diagnostic Ultrasound Systems
Siemens Medical Solutions USA, Inc.
IYN
Jul 19, 2016K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
Esaote, S.p.A., IT
IYN
Jul 13, 2016K161525TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jun 27, 2016K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui), CN
IYN
May 13, 2016K161119SonoSite iViz Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
May 5, 2016K161047LOGIQ P9 and LOGIQ P7
GE Healthcare
IYN
May 4, 2016K1532776200 Ultrasound System and 6250 Ultrasound System
Esaote, S.p.A., IT
IYN
May 2, 2016K160357TRINITY
Koelis, FR
IYN
Apr 26, 2016K160162Voluson P6, Voluson P8
GE Healthcare
IYN
Apr 19, 2016K160674Fujifilm Sonosite Vevo MD Imaging System
FUJIFILM Sonosite, Inc.
IYN
Apr 7, 2016K160343SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
Beijing East Whale Imaging Technology Co., Ltd., CN
IYN
Apr 6, 2016K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affin
Philips Ultrasound, Inc.
IYN
Apr 5, 2016K160734SonoSite SII Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Apr 4, 2016K160790Acclarix LX8 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
Apr 4, 2016K160283S45 Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Apr 1, 2016K160258X5 Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Mar 25, 2016K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Mar 16, 2016K160406FUJIFILM FC1 Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Mar 10, 2016K160078Vivid T8
Ge Medical Systems Ultrasound and Primary Care Diagnotics, L
IYN
Mar 9, 2016K160381TE7 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Feb 26, 2016K160182LOGIQ S7 Expert
GE Healthcare
IYN
Feb 26, 2016K153424E-CUBE i7
Alpinion Medical Systems Co., Ltd., KR
IYN
Feb 25, 2016K160184Voluson S6, Voluson S8, Voluson S10
GE Healthcare
IYN
Feb 2, 2016K153529WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jan 21, 2016K153421HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS
Hitachi Aloka Medical America, Inc.
IYN
Jan 20, 2016K153626SonoSite Edge II Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Jan 13, 2016K152854S50 Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Jan 4, 2016K153037LOGIQ V1/ LOGIQ V2
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Dec 21, 2015K153408HM70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 21, 2015K153085Q Series Diagnostic Ultrasound System
Chison Medical Imaging Co., Ltd., CN
IYN
Dec 16, 2015K153480ClearVue850 Diagnostic Ultrasound System
Philips Health Care
IYN
Dec 9, 2015K152467Touch Ultrasound
Carestream Health, Inc.
IYN
Nov 18, 2015K152758Venue 50
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Nov 12, 2015K152983FUJIFILM SonoSite iViz Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Nov 6, 2015K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
GE Healthcare
IYN
Nov 2, 2015K152962HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Oct 30, 2015K152899Philips Lumify Diagnostic Ultrasound System
Philips Healthcare, Inc.
IYN
Oct 29, 2015K152543M9/M9CV/M9T Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 21, 2015K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Oct 8, 2015K152577ULTRASOUND SYSTEM SONIMAGE HS 1
Konica Minolta, Inc., JP
IYN
Oct 6, 2015K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System
Siemens Medical Solutions USA, Inc. Ultrasound Group
IYN
Oct 5, 2015K151910Ultrasound Scanner System BK2300
Bk Medical Aps, DK
IYN
Oct 2, 2015K152545DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 29, 2015K152195LOGIQ S8
GE Healthcare
IYN
Sep 21, 2015K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System
Siemens Medical Solutions, Inc., Ultrasound Division
IYN
Sep 16, 2015K152052Ultrasound Scanner System bk2300
Bk Medical Aps, DK
IYN
Sep 14, 2015K152309LOGIQ E9, LOGIQ E9 XDClear 2.0
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN

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