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
Jun 6, 2017K170374SonoBook Series Diagnostic Ultrasound System
Chison Medical Imaging Co., Ltd., CN
IYN
May 30, 2017K170521TRINITY/3D PROSTATE SUITE
Koelis, FR
IYN
May 30, 2017K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
Toshibamedical Systems Corporation, JP
IYN
May 30, 2017K163505ARIETTA PRECISION
Hitachi , Ltd.
IYN
May 19, 2017K170303E5 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
May 17, 2017K170078Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley
Medisono, LLC
IYN
Apr 20, 2017K163690DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Apr 13, 2017K163443Interson USB Ultrasound System
Interson Corporation
IYN
Apr 11, 2017K170445LOGIQ S8
GE Healthcare
IYN
Apr 4, 2017K170315Acuson SC2000 Diagnostic Ultrasound System
Siemens Medi Cal Solutions, Inc.
IYN
Mar 28, 2017K170493HS50 / HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Mar 23, 2017K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 16, 2017K1630826200 Ultrasound System and 6250 Ultrasound System
Esaote, S.p.A., IT
IYN
Feb 23, 2017K163688Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10
Medisono, LLC
IYN
Feb 22, 2017K163691HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 10, 2017K163596LOGIQ P9 and LOGIQ P7
GE Healthcare
IYN
Jan 31, 2017K162055Acclarix LX8 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
Jan 12, 2017K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
Siemens Medical Solutions USA, Inc. Ultrasound Group
IYN
Jan 10, 2017K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affi
Philips Ultrasound, Inc.
IYN
Jan 4, 2017K163396ACUSON P500 Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jan 3, 2017K163427X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Dec 15, 2016K162902ARIETTA Prologue Diagnostic Ultrasound system and Transducers
Hitachi , Ltd.
IYN
Dec 15, 2016K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Nov 30, 2016K163138Clarius Ultrasound System
Clarius Mobile Health Corp., CA
IYN
Nov 17, 2016K163077LOGIQ E9, LOGIQ E9 XDClear 2.0
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Nov 17, 2016K162583ALOKA LISENDO 880
Hitachi , Ltd.
IYN
Nov 16, 2016K163020Xperius Ultrasound System
Philips Health Care
IYN
Nov 16, 2016K161999Aixplorer
Supersonic Imagine, FR
IYN
Nov 1, 2016K162155Xario 200 Diagnostic Ultrasound System V5.0
Toshibamedical Systems Corporation, JP
IYN
Oct 21, 2016K160442Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
Neural Analytics, Inc.
IYN
Oct 19, 2016K162065Ultrasound System SONIMAGE HS1
Konica Minolta, Inc., JP
IYN
Oct 18, 2016K160559NOBLUS™ Ultrasound Diagnostic System
Hitachi Medical Corporation
IYN
Oct 17, 2016K161960bk2300
Bk Medical Aps, DK
IYN
Oct 14, 2016K162290MyLabSix CrystaLine
Esaote, S.p.A., IT
IYN
Oct 3, 2016K162549Lumify Ultrasound System
Philips Health Care
IYN
Oct 3, 2016K162269Voluson E6, Voluson E8, Voluson E10
GE Healthcare
IYN
Oct 3, 2016K153539RS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Sep 30, 2016K162187Xario 100 Diagnostic Ultrasound System, V5.0
Toshibamedical Systems Corporation, JP
IYN
Sep 28, 2016K162417Acuson Freestyle Ultrasound System
Siemens Medi Cal Solutions, Inc.
IYN
Sep 21, 2016K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
Toshibamedical Systems Corporation, JP
IYN
Sep 21, 2016K161439E-CUBE 11
Alpinion Medical Systems Co., Ltd., KR
IYN
Sep 14, 2016K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
Philips Health Care
IYN
Sep 14, 2016K162172EBit Series Diagnostic Ultrasound System
Chison Medical Imaging Co., Ltd., CN
IYN
Sep 8, 2016K162288SonoSite iViz Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Sep 6, 2016K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 6, 2016K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
Siemens Medi Cal Solutions, Inc.
IYN
Sep 6, 2016K162221ACUSON SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions Inc. Ultrasound Group
IYN
Sep 2, 2016K161168MyLabSix Ultrasound System
Esaote Europe B.V., NL
IYN
Aug 31, 2016K161588Vscan Extend
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Aug 26, 2016K162094RS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN

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