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
Nov 25, 2025K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
Esaote, S.p.A., IT
IYN
Nov 24, 2025K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Nov 17, 2025K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Nov 13, 2025K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Nov 7, 2025K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Nov 3, 2025K253448Sonosite MT Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Oct 31, 2025K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
Canon Medical Systems Corporation, JP
IYN
Oct 29, 2025K251985LOGIQ E10
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Oct 29, 2025K251963LOGIQ E10s
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Oct 9, 2025K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Oct 1, 2025K250026Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
Wuxi Hisky Medical Technologies Co., Ltd., CN
IYN
Sep 12, 2025K251820ViewMateTM Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 12, 2025K251368FETOLY
Diagnoly, FR
IYN
Sep 5, 2025K251250ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Aug 29, 2025K251106Sonosite LX and Sonosite PX Ultrasound Systems
FUJIFILM Sonosite, Inc.
IYN
Aug 22, 2025K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnosti
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Aug 20, 2025K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
IYN
Jul 25, 2025K251322Venue; Venue Go; Venue Fit; Venue Sprint
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jul 24, 2025K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jul 18, 2025K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultra
Samsung Medison Co., Ltd., KR
IYN
Jul 10, 2025K251830Sonosite LX Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Jul 10, 2025K251169Vivid Pioneer
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jun 18, 2025K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
Jun 18, 2025K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)
Esaote, S.p.A., IT
IYN
May 30, 2025K250024TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
May 29, 2025K250543Voluson™ Performance 16; Voluson™ Performance 18
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 23, 2025K242594DEEPECHO
Deepecho
IYN
May 21, 2025K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
May 19, 2025K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
May 16, 2025K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
May 16, 2025K2416716450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A., IT
IYN
May 15, 2025K242519Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
May 13, 2025K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
Canon Medical Systems Corporation, JP
IYN
May 9, 2025K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
IYN
May 8, 2025K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
Leltek, Inc., TW
IYN
May 8, 2025K242670Lumify Diagnostic Ultrasound System
Philips Ultrasound
IYN
May 1, 2025K250087Vscan Air
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Apr 28, 2025K250030Flash Ultrasound System 5100 Point of Care
Philips Ultrasound, LLC
IYN
Apr 25, 2025K242321Kosmos
EchoNous, Inc.
IYN
Apr 23, 2025K250228eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)
Esonic Technology (Wuhan) Co., Ltd., CN
IYN
Apr 10, 2025K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Apr 3, 2025K243298Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
Carbon (Shenzhen) Medical Device Co., Ltd., CN
IYN
Mar 31, 2025K243178Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2)
Shantou Institute of Ultrasonic Instruments Co., Ltd., CN
IYN
Feb 20, 2025K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Accla
Edan Instruments, Inc., CN
IYN
Feb 20, 2025K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultras
Nurodata, Inc., TW
IYN
Feb 12, 2025K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultra
Samsung Medison Co., Ltd., KR
IYN
Feb 11, 2025K243628Vivid T9/Vivid T8
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Feb 11, 2025K243620Vivid iq
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Feb 6, 2025K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound, LLC
IYN
Jan 17, 2025K243502EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
Olympus Medical Systems Corporation, JP
IYN

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