Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

IYN

System, Imaging, Pulsed Doppler, Ultrasonic

Product code
IYN
Device name
System, Imaging, Pulsed Doppler, Ultrasonic
Device class
Class 2
21 CFR
21 CFR 892.1550
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
167
Summaries archived here
148 (direct download)
510(k) clearances (all years, FDA)
1182 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (167)

Last three years. Most recent: 2026-08-24.

NumberDecision dateApplicantDevice nameSummary
K2540272026-08-24Sonoscape Medical Corp.Digital Color Doppler Ultrasound System (Marvo 95/M…PDF
K2616682026-08-07GE Medical Systems Ultrasound and Prim…Venue GoPDF
K2623112026-08-04Philips Ultrasound, LLCAlturion Series Diagnostic Ultrasound SystemPDF
K2618352026-07-30GE Medical Systems Ultrasound and Prim…LOGIQ FocusPDF
K2612882026-07-30IMGFAX CO., LTD.Handheld Ultrasound ScannerPDF
K2614122026-07-28Samsung Medison Co., Ltd.V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 …PDF
K2612112026-07-27Philips Ultrasound, LLCPhilips EPIQ Series Diagnostic Ultrasound System; Ph…PDF
K2612722026-07-23Esonic Technology (Wuhan) Co., Ltd.ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePas…PDF
K2610812026-07-23Beijing Konted Medical Technology Co.,…Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro…PDF
K2606672026-06-29Philips Ultrasound, LLCAlturion Series Diagnostic Ultrasound SystemPDF
K2608442026-06-16Siemens Medical Solutions USA, Inc.ACUSON Sequoia Diagnostic Ultrasound System;ACUSON S…PDF
K2607482026-06-09E-ScopicsES-SeriesPDF
K2601232026-05-27Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound SystemPDF
K2606802026-05-27Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound Systems; Affiniti …PDF
K2603982026-05-26GE Medical Systems Ultrasound and Prim…LOGIQ ePDF
K2539492026-05-22CHISON Medical Technologies Co., Ltd.SonoPort Series Digital Color Doppler Ultrasound Sys…PDF
K2537202026-05-21Wuhan United Imaging Healthcare Co.,Lt…uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, u…PDF
K2537162026-05-15Wuhan United Imaging Healthcare Co.,Lt…uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Gen…PDF
K2540282026-05-15Sonoscape Medical Corp.Digital Color Doppler Ultrasound System (Autra RS, A…PDF
K2601112026-05-14Mytech Intelligence (Shenzhen) Co., Lt…Palmtop Ultrasound Diagnostic System (MT10P/MT10)PDF
K2608462026-05-11Shenzhen Mindray Bio-Medical Electroni…Diagnostic Ultrasound System (MU9);Diagnostic Ultras…FDA
K2525582026-05-05Philips Ultrasound, LLCLumify Diagnostic Ultrasound SystemPDF
K2611322026-05-05Healium Intelliscan CorporationHealium Intelliscan LX192LCPDF
K2605892026-04-29E-ScopicsES-SeriesPDF
K2532882026-04-06Esaote, S.p.A.6450 Ultrasound System (MyLabE80); 6450 Ultrasound S…PDF
K2527092026-04-02Xuzhou Yongkang Electronic Science Tec…Wireless Probe Type Ultrasound ScannerPDF
K2540992026-03-27Samsung Medison Co., Ltd.EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagno…PDF
K2521482026-03-27Butterfly Network, Inc.Butterfly Gestational Age ToolPDF
K2535952026-03-27Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System, Affiniti S…PDF
K2606732026-03-24GE Medical Systems Ultrasound and Prim…LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGI…FDA
K2524332026-03-16SonioSonio Detect (v3)PDF
K2605952026-03-10FUJIFILM Sonosite, Inc.Sonosite iLOOK Ultrasound SystemPDF
K2530492026-02-11Shenzhen Mindray Bio-Medical Electroni…Resona A10S, Resona A20 Pro, Resona A20T, Resona A20…PDF
K2535972026-01-20Canon Medical Systems CorporationAplio beyond and Aplio me Software V2.0 Diagnostic U…PDF
K2533702026-01-08GE Medical Systems Ultrasound and Prim…LOGIQ TotusPDF
K2533662026-01-07GE Medical Systems Ultrasound and Prim…LOGIQ FortisPDF
K2520182026-01-05Samsung Medison Co., Ltd.HERA Z20 Diagnostic Ultrasound System; HERA Z20e Dia…FDA
K2512682025-12-23Edan Instruments, Inc.Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, …PDF
K2509592025-12-22Bioticsai, Inc.BioticsAIPDF
K2525572025-12-22Philips Ultrasound, LLCLumify Diagnostic Ultrasound SystemPDF
K2524982025-12-05Sonoscape Medical Corp.Digital Color Doppler Ultrasound System (X11 Exp/X11…PDF
K2507912025-12-04Asustek Computer, Inc.ASUS Ultrasound Imaging System (LU800 series)PDF
K2516012025-12-03Shenzhen Mindray Bio-Medical Electroni…Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/…PDF
K2533102025-11-25Esaote, S.p.A.7600 Ultrasound System (MyLabC25); 7600 Ultrasound S…PDF
K2523282025-11-24GE Medical Systems Ultrasound and Prim…Voluson Expert 18; Voluson Expert 20; Voluson Expert…PDF
K2534872025-11-17Siemens Medical Solutions USA, Inc.ACUSON Maple Diagnostic Ultrasound System; ACUSON Ma…PDF
K2534572025-11-13Siemens Medical Solutions USA, Inc.ACUSON Juniper Diagnostic Ultrasound System; ACUSON …PDF
K2518532025-11-07Shenzhen Mindray Bio-Medical Electroni…Consona N5, Consona N5 Pro, Consona N5 Super, Conson…PDF
K2534482025-11-03FUJIFILM Sonosite, Inc.Sonosite MT Ultrasound SystemPDF
K2520742025-10-31Canon Medical Systems CorporationAplio i900, Aplio i800 and Aplio i700 Software V9.0 …FDA
K2519852025-10-29GE Medical Systems Ultrasound and Prim…LOGIQ E10PDF
K2519632025-10-29GE Medical Systems Ultrasound and Prim…LOGIQ E10sFDA
K2516512025-10-09Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System; Affiniti S…PDF
K2500262025-10-01Wuxi Hisky Medical Technologies Co., L…Shear Wave Quantificational Ultrasound Diagnostic Sy…PDF
K2518202025-09-12Shenzhen Mindray Bio-Medical Electroni…ViewMateTM Ultrasound SystemPDF
K2513682025-09-12DiagnolyFETOLYPDF
K2512502025-09-05Shenzhen Mindray Bio-Medical Electroni…ViewMate™ Multi Ultrasound System (VMM-ICE-01); View…PDF
K2511062025-08-29FUJIFILM Sonosite, Inc.Sonosite LX and Sonosite PX Ultrasound SystemsPDF
K2511922025-08-22Shenzhen Mindray Bio-Medical Electroni…Diagnostic Ultrasound System (MX7); Diagnostic Ultra…PDF
K2514812025-08-20Siemens Medical Solutions USA, Inc.ACUSON Sequoia Diagnostic Ultrasound System; ACUSON …PDF
K2513222025-07-25GE Medical Systems Ultrasound and Prim…Venue; Venue Go; Venue Fit; Venue SprintPDF
K2514552025-07-24Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System; Affiniti S…PDF
K2509992025-07-18Samsung Medison Co., Ltd.V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultr…FDA
K2518302025-07-10FUJIFILM Sonosite, Inc.Sonosite LX Ultrasound SystemPDF
K2511692025-07-10GE Medical Systems Ultrasound and Prim…Vivid PioneerPDF
K2508862025-06-18Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound Systems; Affiniti …PDF
K2432532025-06-18Esaote, S.p.A.6600 Ultrasound System (MyLabA50); 6600 Ultrasound S…PDF
K2500242025-05-30Shenzhen Mindray Bio-Medical Electroni…TE Air Diagnostic Ultrasound SystemFDA
K2505432025-05-29GE Medical Systems Ultrasound and Prim…Voluson™ Performance 16; Voluson™ Performance 18PDF
K2425942025-05-23DeepechoDEEPECHOPDF
K2437932025-05-21Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System; Affiniti S…FDA
K2500202025-05-19Shenzhen Mindray Bio-Medical Electroni…Diagnostic Ultrasound System (Recho R9W); Diagnostic…PDF
K2416712025-05-16Esaote, S.p.A.6450 Ultrasound System (MyLabE80); 6450 Ultrasound S…PDF
K2501102025-05-16Shenzhen Mindray Bio-Medical Electroni…Diagnostic Ultrasound System (MX6); Diagnostic Ultra…PDF
K2425192025-05-15Philips UltrasoundLumify Diagnostic Ultrasound SystemPDF
K2428082025-05-13Canon Medical Systems CorporationAplio i900/i800/i700 Diagnostic Ultrasound System, S…FDA
K2511102025-05-09Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound Systems; Affiniti …PDF
K2426702025-05-08Philips UltrasoundLumify Diagnostic Ultrasound SystemPDF
K2432262025-05-08Leltek, Inc.Ultrasound Imaging System (LU700 Series); Ultrasound…PDF
K2500872025-05-01GE Medical Systems Ultrasound and Prim…Vscan AirFDA
K2500302025-04-28Philips Ultrasound, LLCFlash Ultrasound System 5100 Point of CarePDF
K2423212025-04-25EchoNous, Inc.Kosmos—
K2502282025-04-23Esonic Technology (Wuhan) Co., Ltd.eHertz Functional Series Diagnostic Ultrasound Syste…PDF
K2501772025-04-10Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System; Affiniti S…PDF
K2432982025-04-03Carbon (Shenzhen) Medical Device Co., …Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ulti…PDF
K2431782025-03-31Shantou Institute of Ultrasonic Instru…Digital Color Doppler Ultrasound Imaging System (Apo…PDF
K2426812025-02-20Nurodata, Inc.NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUS…PDF
K2502142025-02-20Edan Instruments, Inc.Acclarix AX8 Series Diagnostic Ultrasound System (Mo…PDF
K2437022025-02-12Samsung Medison Co., Ltd.V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultr…PDF
K2436282025-02-11GE Medical Systems Ultrasound and Prim…Vivid T9/Vivid T8PDF
K2436202025-02-11GE Medical Systems Ultrasound and Prim…Vivid iqPDF
K2437942025-02-06Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System; Affiniti S…PDF
K2419492025-01-17Sonoscape Medical Corp.Digital Color Doppler Ultrasound System (P60 Series)PDF
K2435022025-01-17Olympus Medical Systems CorporationEVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3…FDA
K2421682024-12-20GE Medical Systems Ultrasound and Prim…Voluson Expert 18; Voluson Expert 20; Voluson Expert…PDF
K2406762024-12-16Vinno Technology (Suzhou) Co.,LtdULTIMUS Series Ultrasound Diagnostic SystemPDF
K2420202024-12-12Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System; Affiniti S…PDF
K2431322024-12-10Shantou Institute of Ultrasonic Instru…Digital Color Doppler Ultrasound Imaging System (Rea…PDF
K2425112024-12-10Samsung Medison Co., Ltd.V5 Diagnostic Ultrasound System, H5 Diagnostic Ultra…PDF
K2424442024-11-27Samsung Medison Co., Ltd.HERA W10 Diagnostic Ultrasound System; HERA W9 Diagn…PDF
K2425232024-11-19Siemens Medical Solutions USA, Inc.ACUSON Sequoia Diagnostic Ultrasound System; ACUSON …PDF
K2432992024-11-15Siemens Medical Solutions USA, Inc.ACUSON Redwood Diagnostic Ultrasound SystemPDF
K2428002024-11-15Philips Ultrasound, LLCThe 5000 Compact Series Ultrasound SystemsFDA
K2422312024-11-08Shenzhen Mindray Bio-Medical Electroni…Resona A10S, Resona A20 Pro, Resona A20T, Resona A20…PDF
K2415542024-10-24Telefield Medical Imaging (Shenzhen) L…Portable Digital Color Doppler Ultrasound System (SC…PDF
K2419712024-10-11Samsung Medison Co., Ltd.HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound S…PDF
K2409802024-10-07Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound SystemPDF
K2420052024-10-02GE Medical Systems Ultrasound and Prim…Versana Premier; Versana Premier Lotus; LOGIQ FPDF
K2422232024-09-20Supersonic ImagineSuperSonic HepaVuPDF
K2341532024-09-18Edgelife Technologies, LLCEdgeLife Handheld Wireless Ultrasound System (E8200)…PDF
K2412012024-09-16Shenzhen Mindray Bio-Medical Electroni…TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/…PDF
K2414322024-09-12Shenzhen Mindray Bio-Medical Electroni…MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/…PDF
K2415822024-09-12Canon Medical Systems CorporationAplio i900/i800/i700 Diagnostic Ultrasound System, S…PDF
K2413802024-09-11DiagnolyFETOLY-HEARTPDF
K2411612024-09-11Leltek, Inc.Ultrasound Imaging System (LK128L); Ultrasound Imagi…PDF
K2410512024-08-30Vave Health, Inc.Vave Wireless Ultrasound SystemPDF
K2338262024-08-29EchoNous, Inc.Kosmos—
K2419792024-08-22Beijing Konted Medical Technology Co.,…Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpr…PDF
K2336972024-08-09CHISON Medical Technologies Co., Ltd.SonoMax Series Digital Color Doppler Ultrasound Syst…PDF
K2409062024-07-23Shenzhen Mindray Bio-Medical Electroni…TE Air Diagnostic Ultrasound SystemPDF
K2407042024-07-22Siemens Medical Solutions USA, Inc.ACUSON Sequoia Diagnostic Ultrasound System, ACUSON …PDF
K2406312024-06-21Samsung Medison Co., Ltd.V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultras…PDF
K2406842024-06-17Shenzhen Mindray Bio-Medical Electroni…Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Re…PDF
K2339552024-06-14Clarius Mobile Health Corp.Clarius OB AIPDF
K2405162024-06-12Samsung Medison Co., Ltd.RS85 Diagnostic Ultrasound SystemPDF
K2336102024-06-12Siemens Medical Solutions USA, Inc.ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultra…PDF
K2401112024-06-10GE Medical Systems Ultrasound and Prim…VenuePDF
K2341062024-06-10GE Medical Systems Ultrasound and Prim…Venue FitPDF
K2402062024-06-10GE Medical Systems Ultrasound and Prim…Venue SprintPDF
K2400532024-06-10GE Medical Systems Ultrasound and Prim…Venue GoPDF
K2338412024-05-16Qingdao Hisense Medical Equipment Co.,…HD80 Series Ultrasound Diagnostic SystemPDF
K2329082024-05-02Contec Medical Systems Co.,LtdColor Doppler Ultrasound Diagnostic System (CMS1700B…FDA
K2404062024-04-26SonioSonio DetectFDA
K2408502024-04-24Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound Systems; Affiniti …PDF
K2401152024-04-22Shenzhen Mindray Bio-Medical Electroni…Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Re…PDF
K2319302024-03-22Guangdong Youkey Medical Co., Ltd.Digital Ultrasonic Diagnostic Imaging System (Model:…PDF
K2336922024-03-07GE Medical Systems Ultrasound and Prim…Voluson Signature 20, Voluson Signature 18PDF
K2334392024-02-21Qingdao Hisense Medical Equipment Co.,…HD60 Series Ultrasound Diagnostic SystemPDF
K2316592024-02-15MedisonoMS55 Plus Digital Color Doppler Ultrasound System (M…PDF
K2337882024-02-13Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound System, Affiniti S…PDF
K2333942024-01-28Synovis Micro Companies AllianceGem Flow Now (GEM2770-FN)PDF
K2331952024-01-24Canon Medical Systems CorporationAplio i900, Aplio i800 and Aplio i700 Software V8.1 …PDF
K2322852024-01-11Sonoscanner SarlU-Lite PROPDF
K2328082024-01-04Butterfly Network, Inc.Butterfly iQ3 Ultrasound SystemPDF
K2337342023-12-22Interson CorporationInterson USB Ultrasound SystemPDF
K2331122023-12-21Samsung Medison Co., Ltd.HM70 EVO Diagnostic Ultrasound SystemPDF
K2313542023-12-20Beijing Konted Medical Technology Co.,…Pocket Ultrasound System (C10)PDF
K2323812023-12-07GE Medical Systems Ultrasound and Prim…LOGIQ TotusPDF
K2335972023-12-06FUJIFILM Sonosite, Inc.Sonosite LX Ultrasound SystemPDF
K2335452023-11-30Philips Ultrasound, LLCEPIQ Series Diagnostic Ultrasound SystemPDF
K2301792023-11-29Esaote, S.p.A.6440 MyLabX90PDF
K2329882023-11-21Canon Medical Systems CorporationAplio flex and Aplio go Software V2.0 Diagnostic Ult…PDF
K2319412023-11-20FUJIFILM Healthcare Americas Corporati…ARIETTA x10PDF
K2319892023-11-07Ge Medical Systems Ultrasound and Prim…LOGIQ E10s, LOGIQ FortisPDF
K2319662023-11-07GE Medical Systems Ultrasound and Prim…LOGIQ E10PDF
K2321862023-11-03Ge Medical Systems Ultrasound and Prim…LOGIQ eFDA
K2319652023-10-30GE Medical Systems Ultrasound and Prim…Voluson Expert 22, Voluson Expert 20, Voluson Expert…PDF
K2321452023-10-30Siemens Medical Solutions USA, Inc.ACUSON Sequoia Diagnostic Ultrasound System, ACUSON …FDA
K2325002023-10-26Philips UltrasoundLumify Diagnostic Ultrasound SystemPDF
K2316852023-10-26Shenzhen Mindray Bio-Medical Electroni…TE Air Diagnostic Ultrasound SystemPDF
K2315092023-10-24Aco Healthcare Co., Ltd.Aco Apache Ultrasound SystemPDF
K2317642023-10-23Bk Medical ApsUltrasound System 1300PDF
K2327042023-10-05Clarius Mobile Health Corp.Clarius Ultrasound ScannerPDF
K2317722023-10-03Samsung Medison Co., Ltd.V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic…PDF
K2323362023-09-26E-ScopicsES Series V2PDF
K2326172023-09-26Siemens Medical Solutions USA, Inc.ACUSON Maple Diagnostic Ultrasound System, ACUSON Ma…FDA
K2300662023-09-15Shenzhen Wisonic Medical Technology Co…Carnation series Diagnostic Ultrasound SystemPDF

148 summaries are archived here for direct download.

Official FDA classification page: IYN
Classification and pathway per current FDA publications. Data from openFDA (CC0).