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)
10recalls 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
Dec 18, 2018K182595HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Dec 6, 2018K181727Vivid iq
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Dec 4, 2018K1831916420 Ultrasound System
Esaote, S.p.A., IT
IYN
Dec 4, 2018K181336HS50 / HS60 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Nov 21, 2018K182277Versana Premier
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Nov 20, 2018K182715Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technology Co. , Ltd., CN
IYN
Nov 15, 2018K181985Voluson E6, Voluson E8, Voluson E10
GE Healthcare
IYN
Nov 14, 2018K182603Z6 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Nov 9, 2018K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30
Philips Ultrasound, Inc.
IYN
Nov 6, 2018K181934Vivid T8, Vivid T9
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Nov 2, 2018K182596Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
Canon Medical Systems Corporation, JP
IYN
Nov 2, 2018K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
Canon Medical Systems Corporation, JP
IYN
Oct 31, 2018K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
Canon Medical Systems Corporation, JP
IYN
Oct 25, 2018K181685Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Oct 23, 2018K182529Xperius Ultrasound System
Philips Ultrasound, Inc.
IYN
Oct 19, 2018K182450Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Oct 11, 2018K181617E-CUBE 8
Alpinion Medical Systems Co., Ltd., KR
IYN
Sep 28, 2018K181277E-CUBE 12
Alpinion Medical Systems Co., Ltd., KR
IYN
Sep 20, 2018K181783LOGIQ P9; LOGIQ P7
GE Healthcare
IYN
Aug 27, 2018K181313BenQ Diagnostic Ultrasound System
Qisda Corporation, TW
IYN
Aug 17, 2018K180974CBit Series Digital Color Doppler Ultrasound System
CHISON Medical Technologies Co., Ltd., CN
IYN
Aug 1, 2018K180737Ultrasound Scanner System bk2300
Bk Medical Aps, DK
IYN
Jul 30, 2018K180912TE7/TE5 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Jul 27, 2018K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System
Philips Ultrasound, Inc.
IYN
Jul 18, 2018K181376ARIETTA 65
Hitachi Healthcare Americas Corporation
IYN
Jul 11, 2018K173801Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment Co., Ltd., CN
IYN
Jul 11, 2018K173486NTU-USB Ultrasound USB Box
National Taiwan University, TW
IYN
Jun 25, 2018K180995Vscan Extend
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 31, 2018K181098ACUSON SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
May 29, 2018K180572AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
Supersonic Imagine, FR
IYN
May 24, 2018K180862Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
May 22, 2018K180455NeuralBot
Neural Analytics, Inc.
IYN
May 14, 2018K180799Clarius Ultrasound Scanner
Clarius Mobile Health Corp., CA
IYN
May 14, 2018K173810Ventripoint Medical System Plus (VMS+)
Ventripoint Diagnostics , Ltd., CA
IYN
May 11, 2018K180409HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
May 9, 2018K180461Navi e/Navi s/Navi X Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technology Co. , Ltd., CN
IYN
May 2, 2018K180599Venue
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Apr 20, 2018K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound System
Toshibamedical Systems Corporation, JP
IYN
Apr 13, 2018K180704SonoSite iViz Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Apr 13, 2018K180408U60 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYN
Mar 29, 2018K180535Voluson P6 and Voluson P8
GE Healthcare
IYN
Mar 13, 2018K180374Voluson S8/ Voluson S10/ Voluson S10 Expert
GE Healthcare
IYN
Mar 8, 2018K173713HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 28, 2018K173739ALOKA ARIETTA 850
Hitachi Healthcare Americas Corporation
IYN
Feb 23, 2018K173569Ultrasound System 1300
Bk Medical Aps, DK
IYN
Feb 20, 2018K173513WS80A Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 7, 2018K180067ACUSON X800 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Feb 5, 2018K173204RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Feb 2, 2018K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc. Ultrasound Group
IYN
Feb 1, 2018K180039ACUSON P600 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN

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