IYN
- 产品代码
- IYN
- 器械名称
- System, Imaging, Pulsed Doppler, Ultrasonic
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1550
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 1182 件
该代码近三年的 510(k)（167 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K254027 | 2026-08-24 | Sonoscape Medical Corp. | Digital Color Doppler Ultrasound System (Marvo 95/M 摘要 |
| K261668 | 2026-08-07 | GE Medical Systems Ultrasound and Prim | Venue Go 摘要 |
| K262311 | 2026-08-04 | Philips Ultrasound, LLC | Alturion Series Diagnostic Ultrasound System 摘要 |
| K261835 | 2026-07-30 | GE Medical Systems Ultrasound and Prim | LOGIQ Focus 摘要 |
| K261288 | 2026-07-30 | IMGFAX CO., LTD. | Handheld Ultrasound Scanner 摘要 |
| K261412 | 2026-07-28 | Samsung Medison Co., Ltd. | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 摘要 |
| K261211 | 2026-07-27 | Philips Ultrasound, LLC | Philips EPIQ Series Diagnostic Ultrasound System; Ph 摘要 |
| K261272 | 2026-07-23 | Esonic Technology (Wuhan) Co., Ltd. | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePas 摘要 |
| K261081 | 2026-07-23 | Beijing Konted Medical Technology Co., | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro 摘要 |
| K260667 | 2026-06-29 | Philips Ultrasound, LLC | Alturion Series Diagnostic Ultrasound System 摘要 |
| K260844 | 2026-06-16 | Siemens Medical Solutions USA, Inc. | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON S 摘要 |
| K260748 | 2026-06-09 | E-Scopics | ES-Series 摘要 |
| K260123 | 2026-05-27 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System 摘要 |
| K260680 | 2026-05-27 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound Systems; Affiniti 摘要 |
| K260398 | 2026-05-26 | GE Medical Systems Ultrasound and Prim | LOGIQ e 摘要 |
| K253949 | 2026-05-22 | CHISON Medical Technologies Co., Ltd. | SonoPort Series Digital Color Doppler Ultrasound Sys 摘要 |
| K253720 | 2026-05-21 | Wuhan United Imaging Healthcare Co.,Lt | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, u 摘要 |
| K253716 | 2026-05-15 | Wuhan United Imaging Healthcare Co.,Lt | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Gen 摘要 |
| K254028 | 2026-05-15 | Sonoscape Medical Corp. | Digital Color Doppler Ultrasound System (Autra RS, A 摘要 |
| K260111 | 2026-05-14 | Mytech Intelligence (Shenzhen) Co., Lt | Palmtop Ultrasound Diagnostic System (MT10P/MT10) 摘要 |
| K260846 | 2026-05-11 | Shenzhen Mindray Bio-Medical Electroni | Diagnostic Ultrasound System (MU9);Diagnostic Ultras 摘要 |
| K252558 | 2026-05-05 | Philips Ultrasound, LLC | Lumify Diagnostic Ultrasound System 摘要 |
| K261132 | 2026-05-05 | Healium Intelliscan Corporation | Healium Intelliscan LX192LC 摘要 |
| K260589 | 2026-04-29 | E-Scopics | ES-Series 摘要 |
| K253288 | 2026-04-06 | Esaote, S.p.A. | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound S 摘要 |
| K252709 | 2026-04-02 | Xuzhou Yongkang Electronic Science Tec | Wireless Probe Type Ultrasound Scanner 摘要 |
| K254099 | 2026-03-27 | Samsung Medison Co., Ltd. | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagno 摘要 |
| K252148 | 2026-03-27 | Butterfly Network, Inc. | Butterfly Gestational Age Tool 摘要 |
| K253595 | 2026-03-27 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System, Affiniti S 摘要 |
| K260673 | 2026-03-24 | GE Medical Systems Ultrasound and Prim | LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGI 摘要 |
| K252433 | 2026-03-16 | Sonio | Sonio Detect (v3) 摘要 |
| K260595 | 2026-03-10 | FUJIFILM Sonosite, Inc. | Sonosite iLOOK Ultrasound System 摘要 |
| K253049 | 2026-02-11 | Shenzhen Mindray Bio-Medical Electroni | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20 摘要 |
| K253597 | 2026-01-20 | Canon Medical Systems Corporation | Aplio beyond and Aplio me Software V2.0 Diagnostic U 摘要 |
| K253370 | 2026-01-08 | GE Medical Systems Ultrasound and Prim | LOGIQ Totus 摘要 |
| K253366 | 2026-01-07 | GE Medical Systems Ultrasound and Prim | LOGIQ Fortis 摘要 |
| K252018 | 2026-01-05 | Samsung Medison Co., Ltd. | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Dia 摘要 |
| K251268 | 2025-12-23 | Edan Instruments, Inc. | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, 摘要 |
| K250959 | 2025-12-22 | Bioticsai, Inc. | BioticsAI 摘要 |
| K252557 | 2025-12-22 | Philips Ultrasound, LLC | Lumify Diagnostic Ultrasound System 摘要 |
| K252498 | 2025-12-05 | Sonoscape Medical Corp. | Digital Color Doppler Ultrasound System (X11 Exp/X11 摘要 |
| K250791 | 2025-12-04 | Asustek Computer, Inc. | ASUS Ultrasound Imaging System (LU800 series) 摘要 |
| K251601 | 2025-12-03 | Shenzhen Mindray Bio-Medical Electroni | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/ 摘要 |
| K253310 | 2025-11-25 | Esaote, S.p.A. | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound S 摘要 |
| K252328 | 2025-11-24 | GE Medical Systems Ultrasound and Prim | Voluson Expert 18; Voluson Expert 20; Voluson Expert 摘要 |
| K253487 | 2025-11-17 | Siemens Medical Solutions USA, Inc. | ACUSON Maple Diagnostic Ultrasound System; ACUSON Ma 摘要 |
| K253457 | 2025-11-13 | Siemens Medical Solutions USA, Inc. | ACUSON Juniper Diagnostic Ultrasound System; ACUSON 摘要 |
| K251853 | 2025-11-07 | Shenzhen Mindray Bio-Medical Electroni | Consona N5, Consona N5 Pro, Consona N5 Super, Conson 摘要 |
| K253448 | 2025-11-03 | FUJIFILM Sonosite, Inc. | Sonosite MT Ultrasound System 摘要 |
| K252074 | 2025-10-31 | Canon Medical Systems Corporation | Aplio i900, Aplio i800 and Aplio i700 Software V9.0 摘要 |
| K251985 | 2025-10-29 | GE Medical Systems Ultrasound and Prim | LOGIQ E10 摘要 |
| K251963 | 2025-10-29 | GE Medical Systems Ultrasound and Prim | LOGIQ E10s 摘要 |
| K251651 | 2025-10-09 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System; Affiniti S 摘要 |
| K250026 | 2025-10-01 | Wuxi Hisky Medical Technologies Co., L | Shear Wave Quantificational Ultrasound Diagnostic Sy 摘要 |
| K251820 | 2025-09-12 | Shenzhen Mindray Bio-Medical Electroni | ViewMateTM Ultrasound System 摘要 |
| K251368 | 2025-09-12 | Diagnoly | FETOLY 摘要 |
| K251250 | 2025-09-05 | Shenzhen Mindray Bio-Medical Electroni | ViewMate Multi Ultrasound System (VMM-ICE-01); View 摘要 |
| K251106 | 2025-08-29 | FUJIFILM Sonosite, Inc. | Sonosite LX and Sonosite PX Ultrasound Systems 摘要 |
| K251192 | 2025-08-22 | Shenzhen Mindray Bio-Medical Electroni | Diagnostic Ultrasound System (MX7); Diagnostic Ultra 摘要 |
| K251481 | 2025-08-20 | Siemens Medical Solutions USA, Inc. | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON 摘要 |
| K251322 | 2025-07-25 | GE Medical Systems Ultrasound and Prim | Venue; Venue Go; Venue Fit; Venue Sprint 摘要 |
| K251455 | 2025-07-24 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System; Affiniti S 摘要 |
| K250999 | 2025-07-18 | Samsung Medison Co., Ltd. | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultr 摘要 |
| K251830 | 2025-07-10 | FUJIFILM Sonosite, Inc. | Sonosite LX Ultrasound System 摘要 |
| K251169 | 2025-07-10 | GE Medical Systems Ultrasound and Prim | Vivid Pioneer 摘要 |
| K250886 | 2025-06-18 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound Systems; Affiniti 摘要 |
| K243253 | 2025-06-18 | Esaote, S.p.A. | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound S 摘要 |
| K250024 | 2025-05-30 | Shenzhen Mindray Bio-Medical Electroni | TE Air Diagnostic Ultrasound System 摘要 |
| K250543 | 2025-05-29 | GE Medical Systems Ultrasound and Prim | Voluson Performance 16; Voluson Performance 18 摘要 |
| K242594 | 2025-05-23 | Deepecho | DEEPECHO 摘要 |
| K243793 | 2025-05-21 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System; Affiniti S 摘要 |
| K250020 | 2025-05-19 | Shenzhen Mindray Bio-Medical Electroni | Diagnostic Ultrasound System (Recho R9W); Diagnostic 摘要 |
| K241671 | 2025-05-16 | Esaote, S.p.A. | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound S 摘要 |
| K250110 | 2025-05-16 | Shenzhen Mindray Bio-Medical Electroni | Diagnostic Ultrasound System (MX6); Diagnostic Ultra 摘要 |
| K242519 | 2025-05-15 | Philips Ultrasound | Lumify Diagnostic Ultrasound System 摘要 |
| K242808 | 2025-05-13 | Canon Medical Systems Corporation | Aplio i900/i800/i700 Diagnostic Ultrasound System, S 摘要 |
| K251110 | 2025-05-09 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound Systems; Affiniti 摘要 |
| K242670 | 2025-05-08 | Philips Ultrasound | Lumify Diagnostic Ultrasound System 摘要 |
| K243226 | 2025-05-08 | Leltek, Inc. | Ultrasound Imaging System (LU700 Series); Ultrasound 摘要 |
| K250087 | 2025-05-01 | GE Medical Systems Ultrasound and Prim | Vscan Air 摘要 |
| K250030 | 2025-04-28 | Philips Ultrasound, LLC | Flash Ultrasound System 5100 Point of Care 摘要 |
| K242321 | 2025-04-25 | EchoNous, Inc. | Kosmos |
| K250228 | 2025-04-23 | Esonic Technology (Wuhan) Co., Ltd. | eHertz Functional Series Diagnostic Ultrasound Syste 摘要 |
| K250177 | 2025-04-10 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System; Affiniti S 摘要 |
| K243298 | 2025-04-03 | Carbon (Shenzhen) Medical Device Co., | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ulti 摘要 |
| K243178 | 2025-03-31 | Shantou Institute of Ultrasonic Instru | Digital Color Doppler Ultrasound Imaging System (Apo 摘要 |
| K242681 | 2025-02-20 | Nurodata, Inc. | NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUS 摘要 |
| K250214 | 2025-02-20 | Edan Instruments, Inc. | Acclarix AX8 Series Diagnostic Ultrasound System (Mo 摘要 |
| K243702 | 2025-02-12 | Samsung Medison Co., Ltd. | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultr 摘要 |
| K243628 | 2025-02-11 | GE Medical Systems Ultrasound and Prim | Vivid T9/Vivid T8 摘要 |
| K243620 | 2025-02-11 | GE Medical Systems Ultrasound and Prim | Vivid iq 摘要 |
| K243794 | 2025-02-06 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System; Affiniti S 摘要 |
| K241949 | 2025-01-17 | Sonoscape Medical Corp. | Digital Color Doppler Ultrasound System (P60 Series) 摘要 |
| K243502 | 2025-01-17 | Olympus Medical Systems Corporation | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 摘要 |
| K242168 | 2024-12-20 | GE Medical Systems Ultrasound and Prim | Voluson Expert 18; Voluson Expert 20; Voluson Expert 摘要 |
| K240676 | 2024-12-16 | Vinno Technology (Suzhou) Co.,Ltd | ULTIMUS Series Ultrasound Diagnostic System 摘要 |
| K242020 | 2024-12-12 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System; Affiniti S 摘要 |
| K243132 | 2024-12-10 | Shantou Institute of Ultrasonic Instru | Digital Color Doppler Ultrasound Imaging System (Rea 摘要 |
| K242511 | 2024-12-10 | Samsung Medison Co., Ltd. | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultra 摘要 |
| K242444 | 2024-11-27 | Samsung Medison Co., Ltd. | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagn 摘要 |
| K242523 | 2024-11-19 | Siemens Medical Solutions USA, Inc. | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON 摘要 |
| K243299 | 2024-11-15 | Siemens Medical Solutions USA, Inc. | ACUSON Redwood Diagnostic Ultrasound System 摘要 |
| K242800 | 2024-11-15 | Philips Ultrasound, LLC | The 5000 Compact Series Ultrasound Systems 摘要 |
| K242231 | 2024-11-08 | Shenzhen Mindray Bio-Medical Electroni | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20 摘要 |
| K241554 | 2024-10-24 | Telefield Medical Imaging (Shenzhen) L | Portable Digital Color Doppler Ultrasound System (SC 摘要 |
| K241971 | 2024-10-11 | Samsung Medison Co., Ltd. | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound S 摘要 |
| K240980 | 2024-10-07 | Philips Ultrasound, LLC | EPIQ Series Diagnostic Ultrasound System 摘要 |
| K242005 | 2024-10-02 | GE Medical Systems Ultrasound and Prim | Versana Premier; Versana Premier Lotus; LOGIQ F 摘要 |
| K242223 | 2024-09-20 | Supersonic Imagine | SuperSonic HepaVu 摘要 |
| K234153 | 2024-09-18 | Edgelife Technologies, LLC | EdgeLife Handheld Wireless Ultrasound System (E8200) 摘要 |
| K241201 | 2024-09-16 | Shenzhen Mindray Bio-Medical Electroni | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/ 摘要 |
| K241432 | 2024-09-12 | Shenzhen Mindray Bio-Medical Electroni | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/ 摘要 |
| K241582 | 2024-09-12 | Canon Medical Systems Corporation | Aplio i900/i800/i700 Diagnostic Ultrasound System, S 摘要 |
| K241380 | 2024-09-11 | Diagnoly | FETOLY-HEART 摘要 |
| K241161 | 2024-09-11 | Leltek, Inc. | Ultrasound Imaging System (LK128L); Ultrasound Imagi 摘要 |
| K241051 | 2024-08-30 | Vave Health, Inc. | Vave Wireless Ultrasound System 摘要 |
| K233826 | 2024-08-29 | EchoNous, Inc. | Kosmos |
| K241979 | 2024-08-22 | Beijing Konted Medical Technology Co., | Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpr 摘要 |
| K233697 | 2024-08-09 | CHISON Medical Technologies Co., Ltd. | SonoMax Series Digital Color Doppler Ultrasound Syst 摘要 |
| K240906 | 2024-07-23 | Shenzhen Mindray Bio-Medical Electroni | TE Air Diagnostic Ultrasound System 摘要 |
FDA 官方分类页： IYN
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。