System, Imaging, Pulsed Doppler, Ultrasonic
FDA product code IYN · Class II (moderate risk) · 21 CFR 892.1550 · Radiology
1,183510(k) clearances
1PMA approvals
284recalls
Manufacturers
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 83
- Siemens Medical Solutions USA, Inc. 75
- Samsung Medison Co., Ltd. 68
- GE Medical Systems Ultrasound and Primary Care Diagnostics 61
- GE Healthcare, LLC 52
- Philips Ultrasound, Inc 51
- Esaote, S.p.A. 34
- Alpinion Medical Systems Co., Ltd. 25
- FUJIFILM Sonosite, Inc. 25
- General Electric Co. 23
- Sonoscape Medical Corp. 22
- Toshiba America Medical Systems, In.C 22
- Sonoscape Company Limited 18
- Toshibamedical Systems Corporation 18
- Canon Medical Systems Corporation 17
- Aloka Co., Ltd. 17
- Sonosite,Inc. 16
- Medison Co., Ltd. 16
- Supersonic Imagine 15
- Edan Instruments, Inc. 13
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
| K260667 | Alturion Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 06/29/2026SE |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 06/16/2026SE |
| K260748 | ES-SeriesIYN · Traditional | E-Scopics | 06/09/2026SE |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN · Special | Philips Ultrasound, LLC | 05/27/2026SE |
| K260123 | EPIQ Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 05/27/2026SE |
| K260398 | LOGIQ eIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 05/26/2026SE |
| K253949 | SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp…IYN · Traditional | CHISON Medical Technologies Co., Ltd. | 05/22/2026SE |
| K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace…IYN · Traditional | Wuhan United Imaging Healthcare Co.,Ltd | 05/21/2026SE |
| K254028 | Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…IYN · Traditional | Sonoscape Medical Corp. | 05/15/2026SE |
| K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super…IYN · Traditional | Wuhan United Imaging Healthcare Co.,Ltd | 05/15/2026SE |
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10)IYN · Traditional | Mytech Intelligence (Shenzhen) Co., Ltd. | 05/14/2026SE |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/11/2026SE |
| K261132 | Healium Intelliscan LX192LCIYN · Special | Healium Intelliscan Corporation | 05/05/2026SE |
| K252558 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 05/05/2026SE |
| K260589 | ES-SeriesIYN · Special | E-Scopics | 04/29/2026SE |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN · Traditional | Esaote, S.p.A. | 04/06/2026SE |
| K252709 | Wireless Probe Type Ultrasound ScannerIYN · Traditional | Xuzhou Yongkang Electronic Science Technology… | 04/02/2026SE |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…IYN · Traditional | Samsung Medison Co., Ltd. | 03/27/2026SE |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 03/27/2026SE |
| K252148 | Butterfly Gestational Age ToolIYN · Traditional | Butterfly Network, Inc. | 03/27/2026SE |
| K260673 | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ…IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 03/24/2026SE |
| K252433 | Sonio Detect (v3)IYN · Traditional | Sonio | 03/16/2026SE |
| K260595 | Sonosite iLOOK Ultrasound SystemIYN · Traditional | FUJIFILM Sonosite, Inc. | 03/10/2026SE |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 02/11/2026SE |
| K253597 | Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemIYN · Traditional | Canon Medical Systems Corporation | 01/20/2026SE |
| K253370 | LOGIQ TotusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 01/08/2026SE |
| K253366 | LOGIQ FortisIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 01/07/2026SE |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…IYN · Traditional | Samsung Medison Co., Ltd. | 01/05/2026SE |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)IYN · Traditional | Edan Instruments, Inc. | 12/23/2025SE |
| K252557 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 12/22/2025SE |
| K250959 | BioticsAIIYN · Traditional | Bioticsai, Inc. | 12/22/2025SE |
| K252498 | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…IYN · Traditional | Sonoscape Medical Corp. | 12/05/2025SE |
| K250791 | ASUS Ultrasound Imaging System (LU800 series)IYN · Traditional | Asustek Computer, Inc. | 12/04/2025SE |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 12/03/2025SE |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)IYN · Special | Esaote, S.p.A. | 11/25/2025SE |
| K252328 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 11/24/2025SE |
| K253487 | ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 11/17/2025SE |
| K253457 | ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 11/13/2025SE |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 11/07/2025SE |
| K253448 | Sonosite MT Ultrasound SystemIYN · Traditional | FUJIFILM Sonosite, Inc. | 11/03/2025SE |
| K252074 | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemIYN · Traditional | Canon Medical Systems Corporation | 10/31/2025SE |
| K251985 | Logiq E10IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 10/29/2025SE |
| K251963 | LOGIQ E10sIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 10/29/2025SE |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 10/09/2025SE |
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System…IYN · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 10/01/2025SE |
| K251820 | ViewMateTM Ultrasound SystemIYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/12/2025SE |
| K251368 | FetolyIYN · Traditional | Diagnoly | 09/12/2025SE |
| K251250 | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/05/2025SE |
| K251106 | Sonosite LX and Sonosite PX Ultrasound SystemsIYN · Traditional | FUJIFILM Sonosite, Inc. | 08/29/2025SE |
| K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/22/2025SE |
| K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 08/20/2025SE |
| K251322 | Venue; Venue Go; Venue Fit; Venue SprintIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/25/2025SE |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 07/24/2025SE |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…IYN · Traditional | Samsung Medison Co., Ltd. | 07/18/2025SE |
| K251830 | Sonosite LX Ultrasound SystemIYN · Traditional | FUJIFILM Sonosite, Inc. | 07/10/2025SE |
| K251169 | Vivid PioneerIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/10/2025SE |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN · Special | Philips Ultrasound, LLC | 06/18/2025SE |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)IYN · Traditional | Esaote, S.p.A. | 06/18/2025SE |
| K250024 | TE Air Diagnostic Ultrasound SystemIYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/30/2025SE |
| K250543 | Voluson Performance 16; Voluson Performance 18IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 05/29/2025SE |
| K242594 | DeepechoIYN · Traditional | Deepecho | 05/23/2025SE |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 05/21/2025SE |
| K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/19/2025SE |
| K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/16/2025SE |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN · Traditional | Esaote, S.p.A. | 05/16/2025SE |
| K242519 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound | 05/15/2025SE |
| K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5IYN · Traditional | Canon Medical Systems Corporation | 05/13/2025SE |
| K251110 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN · Special | Philips Ultrasound, LLC | 05/09/2025SE |
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…IYN · Special | Leltek, Inc. | 05/08/2025SE |
| K242670 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound | 05/08/2025SE |
| K250087 | Vscan AirIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 05/01/2025SE |
| K250030 | Flash Ultrasound System 5100 Point of CareIYN · Traditional | Philips Ultrasound, LLC | 04/28/2025SE |
| K242321 | KosmosIYN · Traditional | EchoNous, Inc. | 04/25/2025SE |
| K250228 | eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 04/23/2025SE |
| K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 04/10/2025SE |
| K243298 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound SystemIYN · Traditional | Carbon (Shenzhen) Medical Device Co., Ltd. | 04/03/2025SE |
| K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler…IYN · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 03/31/2025SE |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…IYN · Traditional | Edan Instruments, Inc. | 02/20/2025SE |
| K242681 | NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…IYN · Traditional | Nurodata, Inc. | 02/20/2025SE |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…IYN · Traditional | Samsung Medison Co., Ltd. | 02/12/2025SE |
| K243628 | Vivid T9/Vivid T8IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 02/11/2025SE |
| K243620 | Vivid iqIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 02/11/2025SE |
| K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 02/06/2025SE |
| K243502 | Evis Eus Endoscopic Ultrasound Center Olympus EU-ME3 (Olympus EU-ME3)IYN · Traditional | Olympus Medical Systems Corporation | 01/17/2025SE |
| K241949 | Digital Color Doppler Ultrasound System (P60 Series)IYN · Traditional | Sonoscape Medical Corp. | 01/17/2025SE |
| K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 12/20/2024SE |
| K240676 | ULTIMUS Series Ultrasound Diagnostic SystemIYN · Traditional | Vinno Technology (Suzhou) Co.,Ltd | 12/16/2024SE |
| K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 12/12/2024SE |
| K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler…IYN · Traditional | Shantou Institute of Ultrasonic Instruments Co.… | 12/10/2024SE |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…IYN · Traditional | Samsung Medison Co., Ltd. | 12/10/2024SE |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN · Traditional | Samsung Medison Co., Ltd. | 11/27/2024SE |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 11/19/2024SE |
| K243299 | ACUSON Redwood Diagnostic Ultrasound SystemIYN · Traditional | Siemens Medical Solutions USA, Inc. | 11/15/2024SE |
| K242800 | The 5000 Compact Series Ultrasound SystemsIYN · Traditional | Philips Ultrasound, LLC | 11/15/2024SE |
| K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 11/08/2024SE |
| K241554 | Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)IYN · Traditional | Telefield Medical Imaging (Shenzhen) Limited | 10/24/2024SE |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemIYN · Traditional | Samsung Medison Co., Ltd. | 10/11/2024SE |
| K240980 | EPIQ Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 10/07/2024SE |
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ FIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 10/02/2024SE |
| K242223 | SuperSonic HepaVuIYN · Special | Supersonic Imagine | 09/20/2024SE |
| K234153 | EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless…IYN · Traditional | Edgelife Technologies, LLC | 09/18/2024SE |
| K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/16/2024SE |
| K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…IYN · Traditional | Canon Medical Systems Corporation | 09/12/2024SE |
| K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/12/2024SE |
| K241380 | Fetoly-HeartIYN · Traditional | Diagnoly | 09/11/2024SE |
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…IYN · Special | Leltek, Inc. | 09/11/2024SE |
| K241051 | Vave Wireless Ultrasound SystemIYN · Traditional | Vave Health, Inc. | 08/30/2024SE |
| K233826 | KosmosIYN · Traditional | EchoNous, Inc. | 08/29/2024SE |
| K241979 | Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 08/22/2024SE |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound SystemIYN · Traditional | CHISON Medical Technologies Co., Ltd. | 08/09/2024SE |
| K240906 | TE Air Diagnostic Ultrasound SystemIYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/23/2024SE |
| K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 07/22/2024SE |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemIYN · Traditional | Samsung Medison Co., Ltd. | 06/21/2024SE |
| K240684 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/17/2024SE |
| K233955 | Clarius OB AIIYN · Traditional | Clarius Mobile Health Corp. | 06/14/2024SE |
| K240516 | RS85 Diagnostic Ultrasound SystemIYN · Traditional | Samsung Medison Co., Ltd. | 06/12/2024SE |
| K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemIYN · Special | Siemens Medical Solutions USA, Inc. | 06/12/2024SE |
| K240206 | Venue SprintIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 06/10/2024SE |
| K240111 | VenueIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 06/10/2024SE |
| K240053 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 06/10/2024SE |
| K234106 | Venue FitIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 06/10/2024SE |
| K233841 | HD80 Series Ultrasound Diagnostic SystemIYN · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 05/16/2024SE |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…IYN · Traditional | Contec Medical Systems Co.,Ltd | 05/02/2024SE |
| K240406 | Sonio DetectIYN · Traditional | Sonio | 04/26/2024SE |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN · Special | Philips Ultrasound, LLC | 04/24/2024SE |
| K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/22/2024SE |
| K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6)IYN · Traditional | Guangdong Youkey Medical Co., Ltd. | 03/22/2024SE |
| K233692 | Voluson Signature 20, Voluson Signature 18IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 03/07/2024SE |
| K233439 | HD60 Series Ultrasound Diagnostic SystemIYN · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 02/21/2024SE |
| K231659 | MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color…IYN · Traditional | Medisono | 02/15/2024SE |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 02/13/2024SE |
| K233394 | Gem Flow Now (GEM2770-FN)IYN · Traditional | Synovis Micro Companies Alliance | 01/28/2024SE |
| K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemIYN · Traditional | Canon Medical Systems Corporation | 01/24/2024SE |
| K232285 | U-Lite PROIYN · Traditional | Sonoscanner Sarl | 01/11/2024SE |
| K232808 | Butterfly iQ3 Ultrasound SystemIYN · Traditional | Butterfly Network, Inc. | 01/04/2024SE |
| K233734 | Interson USB Ultrasound SystemIYN · Special | Interson Corporation | 12/22/2023SE |
| K233112 | HM70 EVO Diagnostic Ultrasound SystemIYN · Traditional | Samsung Medison Co., Ltd. | 12/21/2023SE |
| K231354 | Pocket Ultrasound System (C10)IYN · Traditional | Beijing Konted Medical Technology Co.,Ltd | 12/20/2023SE |
| K232381 | LOGIQ TotusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 12/07/2023SE |
| K233597 | Sonosite LX Ultrasound SystemIYN · Traditional | FUJIFILM Sonosite, Inc. | 12/06/2023SE |
| K233545 | EPIQ Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 11/30/2023SE |
| K230179 | 6440 MyLabX90IYN · Traditional | Esaote, S.p.A. | 11/29/2023SE |
| K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound SystemIYN · Traditional | Canon Medical Systems Corporation | 11/21/2023SE |
| K231941 | ARIETTA x10IYN · Traditional | FUJIFILM Healthcare Americas Corporation | 11/20/2023SE |
| K231989 | LOGIQ E10s, LOGIQ FortisIYN · Traditional | Ge Medical Systems Ultrasound and Primary Care… | 11/07/2023SE |
| K231966 | Logiq E10IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 11/07/2023SE |
| K232186 | LOGIQ eIYN · Traditional | Ge Medical Systems Ultrasound and Primary Care… | 11/03/2023SE |
| K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 10/30/2023SE |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 10/30/2023SE |
| K232500 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound | 10/26/2023SE |
| K231685 | TE Air Diagnostic Ultrasound SystemIYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10/26/2023SE |
| K231509 | Aco Apache Ultrasound SystemIYN · Traditional | Aco Healthcare Co., Ltd. | 10/24/2023SE |
| K231764 | Ultrasound System 1300IYN · Traditional | Bk Medical Aps | 10/23/2023SE |
| K232704 | Clarius Ultrasound ScannerIYN · Special | Clarius Mobile Health Corp. | 10/05/2023SE |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…IYN · Traditional | Samsung Medison Co., Ltd. | 10/03/2023SE |
| K232617 | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 09/26/2023SE |
| K232336 | ES Series V2IYN · Special | E-Scopics | 09/26/2023SE |
| K230066 | Carnation series Diagnostic Ultrasound SystemIYN · Traditional | Shenzhen Wisonic Medical Technology Co. , Ltd. | 09/15/2023SE |
| K231301 | Vscan AirIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 08/15/2023SE |
| K230365 | Sonio DetectIYN · Traditional | Sonio | 07/25/2023SE |
| K230160 | Vinno G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, Vinno…IYN · Traditional | Vinno Technology (Suzhou) Co.,Ltd | 06/23/2023SE |
| K230346 | Voluson SWIFT; Voluson SWIFT+IYN · Traditional | Ge Medical Systems Ultrasound & Primary Care… | 06/20/2023SE |
| K223920 | Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55…IYN · Traditional | Vinno Technology (Suzhou) Co.,Ltd | 06/17/2023SE |
| K223917 | Vinno E20, Vinno E10,VINNO E10P,VINNO E10E, Vinno X1,VINNO X1E,VINNO X1P, Vinno X2,VINNO…IYN · Traditional | Vinno Technology (Suzhou) Co.,Ltd | 06/17/2023SE |
| K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/09/2023SE |
| K231190 | EPIQ Series Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound, LLC | 05/12/2023SE |
| K223771 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | Philips Ultrasound | 05/04/2023SE |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN · Traditional | Samsung Medison Co., Ltd. | 04/21/2023SE |
| K223564 | X-Cube 50, X-Cube 60IYN · Traditional | Alpinion Medical Systems Co., Ltd. | 04/17/2023SE |
| K223830 | Ultrasound System 2300IYN · Traditional | Bk Medical Aps | 04/11/2023SE |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound SystemIYN · Traditional | CHISON Medical Technologies Co., Ltd. | 03/31/2023SE |
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0IYN · Traditional | Canon Medical Systems Corporation | 03/31/2023SE |
| K223832 | Vivid S60N, Vivid S70NIYN · Traditional | Ge Medical System Ultrasound and Primary Care… | 02/16/2023SE |
| K223407 | Versana EssentialIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 02/15/2023SE |
| K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…IYN · Traditional | Siemens Medical Solutions USA, Inc. | 02/13/2023SE |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN · Traditional | Samsung Medison Co., Ltd. | 02/13/2023SE |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound SystemIYN · Traditional | Sonoscape Medical Corp. | 02/10/2023SE |
| K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic…IYN · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 02/07/2023SE |
| K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Special | Siemens Medical Solutions USA, Inc. | 02/06/2023SE |
| K221911 | Vinno 6PRO, Vinno 6EXP, Vinno 5PRO, Vinno 5EXP, Vinno 3, Vinno 3PRO, Vinno 3EXPIYN · Special | Vinno Technology (Suzhou) Co.,Ltd | 12/21/2022SE |
| K222441 | Ultrasound System 2300IYN · Traditional | Bk Medical Aps | 12/07/2022SE |
| K220983 | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging SystemIYN · Traditional | Imsonic Medical China, Inc. | 11/11/2022SE |
| K222754 | ViewMate Multi Ultrasound SystemIYN · Traditional | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 11/09/2022SE |
| K222198 | Exo Iris (El2001)IYN · Traditional | Exo Imaging, Inc. | 11/09/2022SE |
| K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC…IYN · Traditional | Supersonic Imagine | 10/28/2022SE |
| K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series)IYN · Traditional | Leltek, Inc. | 10/25/2022SE |
| K221093 | X-Cube 70, X-Cube 90IYN · Traditional | Alpinion Medical Systems Co., Ltd. | 10/14/2022SE |
| K220857 | X-Cube 50, X-Cube 60IYN · Traditional | Alpinion Medical Systems Co., Ltd. | 10/13/2022SE |
| K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…IYN · Abbreviated | Guangzhou Sonostar Technologies Co., Ltd. | 10/13/2022SE |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…IYN · Traditional | Bionet Co., Ltd. | 10/11/2022SE |
PMA approvals
- P940005 Ultramark 9 High Definition Imaging Uultrasound System · Advanced Technology Laboratories, Inc. · 04/11/1996
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3249-2026 | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual… | Philips Ultrasound, LLC | 08/07/2026Open, Classified |
| Z-0883-2026 Class II | Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live… | Philips Ultrasound, LLC | 10/31/2025Open, Classified |
| Z-0440-2026 Class II | bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler…GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not… | B-K Medical A/S | 10/09/2025Open, Classified |
| Z-0439-2026 Class II | bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler…GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not… | B-K Medical A/S | 10/09/2025Open, Classified |
| Z-0438-2026 Class II | bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler…GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not… | B-K Medical A/S | 10/09/2025Open, Classified |
| Z-0437-2026 Class II | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed…GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not… | B-K Medical A/S | 10/09/2025Open, Classified |
| Z-0436-2026 Class II | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System…GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not… | B-K Medical A/S | 10/09/2025Open, Classified |
| Z-0435-2026 Class II | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus…GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not… | B-K Medical A/S | 10/09/2025Open, Classified |
| Z-0157-2026 Class II | LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values… | GE Medical Systems, LLC | 09/18/2025Open, Classified |
| Z-0156-2026 Class II | LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number…The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values… | GE Medical Systems, LLC | 09/18/2025Open, Classified |
| Z-0155-2026 Class II | LOGIQ P10 series with software version R4.5.7 Model Number 5877534The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values… | GE Medical Systems, LLC | 09/18/2025Open, Classified |
| Z-2414-2025 Class III | XL14-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2413-2025 Class III | X8-2t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2412-2025 Class III | X7-2t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2411-2025 Class III | X7-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2410-2025 Class III | X6-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2409-2025 Class III | X5-1c Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2408-2025 Class III | X5-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2407-2025 Class III | X3-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2406-2025 Class III | X11-4t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2405-2025 Class III | VL13-5 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2404-2025 Class III | V9-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2403-2025 Class III | V6-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2402-2025 Class III | TRANSDUCER L12-5 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2401-2025 Class III | Transducer C10-3v Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2399-2025 Class III | S9-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2398-2025 Class III | S8-3t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2397-2025 Class III | S8-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2396-2025 Class III | S7-2t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2395-2025 Class III | S7-3t Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2394-2025 Class III | S5-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2393-2025 Class III | S4-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2392-2025 Class III | S4-1 Lumify Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2391-2025 Class III | S4-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2390-2025 Class III | S3-1 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2389-2025 Class III | S12-4 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2388-2025 Class III | OMNI III TEE Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2387-2025 Class III | OMNI II TEE Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2386-2025 Class III | mL26-8 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2385-2025 Class III | Mini Multi TEE Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2384-2025 Class III | mC7-2 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2383-2025 Class III | mC12-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2382-2025 Class III | L9-3 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2381-2025 Class III | L8-4 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2380-2025 Class III | L18-5 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2379-2025 Class III | L17-5 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2378-2025 Class III | L15-7IO TRANSDUCER Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2377-2025 Class III | L15-7io Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2376-2025 Class III | L12-5 50 Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2375-2025 Class III | L12-5 38mm Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |