AI devices with FDA product code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Product code IYN (“System, Imaging, Pulsed Doppler, Ultrasonic” in openFDA) covers 124 devices on the FDA AI-enabled list, from 39 companies. Most are reviewed by the Radiology panel (124). The most recent decision was Alturion Series Diagnostic Ultrasound System on June 29, 2026.
124AI devices
29Companies
2016First decision
2026-06-29Latest decision
Trend: devices per year
20162017201820192020202120222023202420252026
Top companies
All 124 devices, newest first
- Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · Radiology
- uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteWuhan United Imaging Healthcare Co.,Ltd · Radiology
- uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperWuhan United Imaging Healthcare Co.,Ltd · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote, S.p.A. · Radiology
- Butterfly Gestational Age ToolButterfly Network, Inc. · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Sonio Detect (v3)Sonio · Radiology
- LOGIQ TotusGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- BioticsAIBioticsai, Inc. · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)Esaote, S.P.A. · Radiology
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22Ge Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation · Radiology
- LOGIQ E10Ge Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- LOGIQ E10sGe Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- FETOLYDiagnoly · Radiology
- Sonosite LX and Sonosite PX Ultrasound SystemsFujifilm Sonosite Inc · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- Venue; Venue Go; Venue Fit; Venue SprintGE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Vivid PioneerGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)Esaote S.p.A. · Radiology
- Voluson Performance 16; Voluson Performance 18GE Medical Systems Ultrasound and Primary care Diagnostics · Radiology
- DEEPECHODeepEcho · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)Esaote S.p.A. · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- Vscan AirGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Vivid T9/Vivid T8GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Vivid iqGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- Digital Color Doppler Ultrasound System (P60 Series)Sonoscape Medical Corp. · Radiology
- Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics · Radiology
- EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- Versana Premier; Versana Premier Lotus; LOGIQ FGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)Canon Medical Systems Corporation · Radiology
- FETOLY-HEARTDiagnoly · Radiology
- KosmosEchoNous, Inc. · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions, USA, Inc. · Radiology
- V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Clarius OB AIClarius Mobile Health Corp. · Radiology
- RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Sonio DetectSonio · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound LLC · Radiology
- Voluson Signature 20, Voluson Signature 18GE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation · Radiology
- Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. · Radiology
- HM70 EVO Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- LOGIQ TotusGE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- 6440 MyLabX90Esaote S.p.A. · Radiology
- LOGIQ E10GE Medical Systems Ultrasound and Primary care Diagnostics, · Radiology
- LOGIQ E10s, LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostic, · Radiology
- Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · Radiology
- Ultrasound System 1300BK Medical Aps · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Sonio DetectSonio · Radiology
- Voluson SWIFT; Voluson SWIFT+GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound LLC · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · Radiology
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- Ultrasound System 2300BK Medical Aps · Radiology
- V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and · Radiology
- Vivid iqGE Medical Systems Ultrasound & Primary Care Diagnostics LLC · Radiology
- Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- VenueGE Medical Systems · Radiology
- Venue FitGE Medical Systems · Radiology
- Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Voluson Expert 22, Voluson Expert 20, Voluson Expert 18GE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Versana BalanceGE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., LTD · Radiology
- Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · Radiology
- Voluson P6, Voluson P8GE Healthcare · Radiology
- Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation · Radiology
- Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE Healthcare · Radiology
- TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co.,LTD · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems · Radiology
- Versana PremierGE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems · Radiology
- KosmosEchoNous, Inc. · Radiology
- HS40 Diagnostic Ultrasound SystemSamsung Medison CO., LTD. · Radiology
- Vivid iqGE Medical Systems Ultrasound and · Radiology
- Vivid T8, Vivid T9GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- Vivid E80/ Vivid E90/ Vivid E95GE Medical Systems Ultrasound and · Radiology
- Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
- EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · Radiology
- KOSMOSEchoNous, Inc. · Radiology
- SonoVision Ultrasound Imaging SystemTissue Differentiation Intelligence, LLC · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Clarius Ultrasound ScannerClarius Mobile Health Corp. · Radiology
- Ventripoint Medical System Plus (VMS+)Ventripoint Diagnostics, Ltd. · Radiology
- VenueGE Medical Systems Ultrasound and Primary Care Diagnostics, · Radiology
- Clarius Ultrasound SystemClarius Mobile Health Corp. · Radiology
- Clarius Ultrasound SystemClarius Mobile Health Corp. · Radiology