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124 devices · 39 companies · 2016 to 2026

Product code IYN: System, Imaging, Pulsed Doppler, Ultrasonic

124 devices under product code IYN, 2016 to 2026, from 39 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (119 of 124 here), the regulation, and MAUDE report counts by product code.

System, Imaging, Pulsed Doppler, Ultrasonic. 21 CFR 892.1550, Class II. MAUDE held 2,748 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.

Retrieved from FDA public records.

Companies with more than one device here

Every device, newest decision first

IYN · 124 devices
DecisionDeviceCompanyPanelFDA
Alturion Series Diagnostic Ultrasound SystemK260667 · 510(k)Philips Ultrasound, LLCRadiologydatabase entry
ACUSON Sequoia Diagnostic Ultrasound SystemK260844 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK260123 · 510(k)Philips Ultrasound, LLCRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK260680 · 510(k)Philips Ultrasound, LLCRadiologydatabase entry
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE VitK253720 · 510(k)Wuhan United Imaging Healthcare Co.,LtdRadiologydatabase entry
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUEK253716 · 510(k)Wuhan United Imaging Healthcare Co.,LtdRadiologydatabase entry
Lumify Diagnostic Ultrasound SystemK252558 · 510(k)Philips Ultrasound, LLCRadiologydatabase entry
6450 Ultrasound SystemK253288 · 510(k)Esaote, S.p.A.Radiologydatabase entry
Butterfly Gestational Age ToolK252148 · 510(k)Butterfly Network, Inc.Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound System, AffiniK253595 · 510(k)Philips Ultrasound, LLCRadiologydatabase entry
LOGIQ VitaK260673 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
Sonio DetectK252433 · 510(k)SonioRadiologydatabase entry
LOGIQ TotusK253370 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
LOGIQ FortisK253366 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
HERA Z20 Diagnostic Ultrasound SystemK252018 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
BioticsAIK250959 · 510(k)Bioticsai, Inc.Radiologydatabase entry
Lumify Diagnostic Ultrasound SystemK252557 · 510(k)Philips Ultrasound, LLCRadiologydatabase entry
7600 Ultrasound SystemK253310 · 510(k)Esaote, S.P.A.Radiologydatabase entry
Voluson Expert 18K252328 · 510(k)Ge Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
Aplio i900, Aplio i800 and Aplio i700 Software VK252074 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
LOGIQ E10K251985 · 510(k)Ge Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
LOGIQ E10sK251963 · 510(k)Ge Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK251651 · 510(k)Philips Ultrasound, LLCRadiologydatabase entry
FETOLYK251368 · 510(k)DiagnolyRadiologydatabase entry
Sonosite LX and Sonosite PX Ultrasound SystemsK251106 · 510(k)Fujifilm Sonosite IncRadiologydatabase entry
ACUSON Sequoia Diagnostic Ultrasound SystemK251481 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
VenueK251322 · 510(k)GE Medical Systems Ultrasound and Primary care Diagnostics,Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK251455 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
V8 Diagnostic Ultrasound SystemK250999 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
Vivid PioneerK251169 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK250886 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
6600 Ultrasound SystemK243253 · 510(k)Esaote S.p.A.Radiologydatabase entry
Voluson Performance 16K250543 · 510(k)GE Medical Systems Ultrasound and Primary care DiagnosticsRadiologydatabase entry
DEEPECHOK242594 · 510(k)DeepEchoRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK243793 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
6450 Ultrasound SystemK241671 · 510(k)Esaote S.p.A.Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK251110 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
Vscan AirK250087 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK250177 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
V8 Diagnostic Ultrasound SystemK243702 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
Vivid T9/Vivid T8K243628 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
Vivid iqK243620 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK243794 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
Digital Color Doppler Ultrasound SystemK241949 · 510(k)Sonoscape Medical Corp.Radiologydatabase entry
Voluson Expert 18K242168 · 510(k)GE Medical Systems Ultrasound and Primary care DiagnosticsRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK242020 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
V5 Diagnostic Ultrasound System, H5 Diagnostic UK242511 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
HERA W10 Diagnostic Ultrasound SystemK242444 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
ACUSON Sequoia Diagnostic Ultrasound SystemK242523 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
The 5000 Compact Series Ultrasound SystemsK242800 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
HERA Z20, R20, HERA Z30, R30 Diagnostic UltrasouK241971 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK240980 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
Versana PremierK242005 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
Aplio i900/i800/i700 Diagnostic Ultrasound SysteK241582 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
FETOLY-HEARTK241380 · 510(k)DiagnolyRadiologydatabase entry
KosmosK233826 · 510(k)EchoNous, Inc.Radiologydatabase entry
ACUSON Sequoia Diagnostic Ultrasound System, ACUK240704 · 510(k)Siemens Medical Solutions, USA, Inc.Radiologydatabase entry
V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic UlK240631 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
Clarius OB AIK233955 · 510(k)Clarius Mobile Health Corp.Radiologydatabase entry
RS85 Diagnostic Ultrasound SystemK240516 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
Sonio DetectK240406 · 510(k)SonioRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemsK240850 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
Voluson Signature 20, Voluson Signature 18K233692 · 510(k)GE Medical Systems Ultrasound and Primary care Diagnostics,Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound System, AffiniK233788 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
Aplio i900, Aplio i800 and Aplio i700 Software VK233195 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Butterfly iQ3 Ultrasound SystemK232808 · 510(k)Butterfly Network, Inc.Radiologydatabase entry
HM70 EVO Diagnostic Ultrasound SystemK233112 · 510(k)Samsung Medison CO., LTD.Radiologydatabase entry
LOGIQ TotusK232381 · 510(k)GE Medical Systems Ultrasound and Primary care Diagnostics,Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK233545 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
6440 MyLabX90K230179 · 510(k)Esaote S.p.A.Radiologydatabase entry
LOGIQ E10K231966 · 510(k)GE Medical Systems Ultrasound and Primary care Diagnostics,Radiologydatabase entry
LOGIQ E10s, LOGIQ FortisK231989 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostic,Radiologydatabase entry
Voluson Expert 22, Voluson Expert 20, Voluson ExK231965 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
ACUSON Sequoia Diagnostic Ultrasound System, ACUK232145 · 510(k)Siemens Medical Solutions USA, Inc.Radiologydatabase entry
Lumify Diagnostic Ultrasound SystemK232500 · 510(k)Philips UltrasoundRadiologydatabase entry
Ultrasound System 1300K231764 · 510(k)BK Medical ApsRadiologydatabase entry
Clarius Ultrasound ScannerK232704 · 510(k)Clarius Mobile Health Corp.Radiologydatabase entry
V8/H8 Diagnostic Ultrasound System, V7/H7 DiagnoK231772 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
Sonio DetectK230365 · 510(k)SonioRadiologydatabase entry
Voluson SWIFTK230346 · 510(k)GE Medical Systems Ultrasound & Primary Care Diagnostic, LLCRadiologydatabase entry
EPIQ Series Diagnostic Ultrasound SystemK231190 · 510(k)Philips Ultrasound LLCRadiologydatabase entry
Lumify Diagnostic Ultrasound SystemK223771 · 510(k)Philips UltrasoundRadiologydatabase entry
HERA W10 Diagnostic Ultrasound SystemK230084 · 510(k)Samsung Medison CO., LTD.Radiologydatabase entry
Ultrasound System 2300K223830 · 510(k)BK Medical ApsRadiologydatabase entry
V8 Diagnostic Ultrasound System, V7 Diagnostic UK223387 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
HS40 Diagnostic Ultrasound SystemK221599 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
Vivid E80, Vivid E90, Vivid E95K220882 · 510(k)GE Medical Systems Ultrasound andRadiologydatabase entry
Vivid iqK221148 · 510(k)GE Medical Systems Ultrasound & Primary Care Diagnostics LLCRadiologydatabase entry
Vivid T8, Vivid T9K221147 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
Vivid S60N, Vivid S70NK220619 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
V8 Diagnostic Ultrasound System, V7 Diagnostic UK220975 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
VenueK220851 · 510(k)GE Medical SystemsRadiologydatabase entry
Venue FitK220848 · 510(k)GE Medical SystemsRadiologydatabase entry
Venue GoK220800 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
Voluson Expert 22, Voluson Expert 20, Voluson ExK220358 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
Versana BalanceK220446 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
HERA W10 Diagnostic Ultrasound System, HERA W9 DK220043 · 510(k)Samsung Medison Co., LTDRadiologydatabase entry
Aplio a550, Aplio a450, and Aplio a, DiagnosticK212960 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Voluson P6, Voluson P8K213689 · 510(k)GE HealthcareRadiologydatabase entry
Aplio i900/i800/i700 Diagnostic Ultrasound SysteK212333 · 510(k)Canon Medical Systems CorporationRadiologydatabase entry
Voluson S6, Voluson S8, Voluson S8t, Voluson S10K213642 · 510(k)GE HealthcareRadiologydatabase entry
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 ElK212265 · 510(k)Shenzhen Mindray Bio-Medical Electronics Co.,LTDRadiologydatabase entry
Clarius Ultrasound ScannerK213436 · 510(k)Clarius Mobile Health Corp.Radiologydatabase entry
Philips EPIQ Diagnostic Ultrasound System, PhiliK212704 · 510(k)Philips Medical SystemsRadiologydatabase entry
Versana PremierK210438 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
HERA W9, HERA W10 Diagnostic Ultrasound SystemK211824 · 510(k)Samsung Medison Co., Ltd.Radiologydatabase entry
V8 Diagnostic Ultrasound SystemK211945 · 510(k)Samsung Medison CO., LTD.Radiologydatabase entry
EPIQ Series Diagnostic Ultrasound System, AffiniK211597 · 510(k)Philips Medical SystemsRadiologydatabase entry
KosmosK212100 · 510(k)EchoNous, Inc.Radiologydatabase entry
HS40 Diagnostic Ultrasound SystemK210426 · 510(k)Samsung Medison CO., LTD.Radiologydatabase entry
Vivid iqK200708 · 510(k)GE Medical Systems Ultrasound andRadiologydatabase entry
Vivid T8, Vivid T9K200851 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
Vivid E80/ Vivid E90/ Vivid E95K200743 · 510(k)GE Medical Systems Ultrasound andRadiologydatabase entry
Vivid S60N, Vivid S70NK200497 · 510(k)GE Medical Systems Ultrasound and Primary Care DiagnosticsRadiologydatabase entry
EPIQ Diagnostic Ultrasound System Series, AffiniK201012 · 510(k)Philips Ultrasound, Inc.Radiologydatabase entry
KOSMOSK193518 · 510(k)EchoNous, Inc.Radiologydatabase entry
SonoVision Ultrasound Imaging SystemK192388 · 510(k)Tissue Differentiation Intelligence, LLCRadiologydatabase entry
Clarius Ultrasound ScannerK192107 · 510(k)Clarius Mobile Health Corp.Radiologydatabase entry
Vivid E80, Vivid E90, Vivid E95K181685 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
Clarius Ultrasound ScannerK180799 · 510(k)Clarius Mobile Health Corp.Radiologydatabase entry
Ventripoint Medical System PlusK173810 · 510(k)Ventripoint Diagnostics, Ltd.Radiologydatabase entry
VenueK180599 · 510(k)GE Medical Systems Ultrasound and Primary Care Diagnostics,Radiologydatabase entry
Clarius Ultrasound SystemK172385 · 510(k)Clarius Mobile Health Corp.Radiologydatabase entry
Clarius Ultrasound SystemK163138 · 510(k)Clarius Mobile Health Corp.Radiologydatabase entry

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