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IYO

System, Imaging, Pulsed Echo, Ultrasonic

产品代码
IYO
器械名称
System, Imaging, Pulsed Echo, Ultrasonic
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 892.1560
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)
30 件
其中 Summary 已存档
26 份,可直接下载
FDA 历史累计 510(k)
894 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(30 件)

数据窗口为最近三年。最新一件:2026-07-24。

510(k) 号批准日期申请人器械名称摘要
K2534522026-07-24Rivanna Medical, Inc.Accuro 3SPDF
K2601902026-06-18ROPCA ApSARTHURPDF
K2522372026-04-17Edgecare, Inc.EdgeFlow UW20PDF
K2540212026-04-09Rivanna Medical, Inc.Accuro XVPDF
K2538982026-03-04QT Imaging Holdings, Inc.QT Scanner 2000 Model APDF
K2537142026-02-24Philips Image Guided Therapy Corporati…IntraSight PlusPDF
K2532212026-02-06Eieling Technology (Shenzhen) LimitedLiver fat ultrasound quantitative system, The FattaL…PDF
K2503312025-09-30Astrasono Technology Co., Ltd.Astrasono A3Pro Bladder Scanner (A3Pro)PDF
K2503812025-08-01DeepSight Technology, Inc.Deepsight NeedleVue LC1 Ultrasound SystemPDF
K2432272025-07-11Accutome, Inc. Doing Business AS Keele…B-ScanFDA
K2517282025-06-26Sonic Incytes Medical CorpVelacur One (LI-1100)PDF
K2438802025-06-17Wuxi Hisky Medical Technologies Co., L…Shear Wave Quantificational Ultrasound Diagnostic Sy…PDF
K2439372025-05-23Rivanna Medical, Inc.Accuro 3SPDF
K2434792025-04-23Sonavex, Inc.EchoGuide (Version 1)PDF
K2424962024-11-19Eieling Technology (Shenzhen) LimitedPortable Liver Elastography Ultrasound Diagnostic Sy…PDF
K2410292024-10-07Verdure ImagingSpineUs™ SystemFDA
K2339772024-09-04Sonic IncytesVelacurPDF
K2335792024-06-26Fcu Co., Ltd.SC1 Handheld Ultrasound Imaging system (Model: SC1)PDF
K2336132024-06-12Siemens Medical Solutions USA, Inc.ACUSON SC2000 Diagnostic Ultrasound SystemPDF
K2328952024-05-03Contec Medical Systems Co.,LtdB-Ultrasound Diagnostic SystemPDF
K2323022024-04-26Quantel MedicalPocket IIIPDF
K2316772024-03-06Edgecare, Inc.EdgeFlow UH10FDA
K2401462024-02-18Bard Access Systems, Inc.BD Prevue™ II Peripheral Vascular Access SystemPDF
K2334012024-02-12Eieling Technology LimitedPortable Liver Elastography Ultrasound Diagnostic Sy…FDA
K2309862023-12-29Avantsonic Technology Co., Ltd.Bladder ScannerPDF
K2323202023-12-21Biobot Surgical Pte., Ltd.iSR`obot Mona Lisa 2.0PDF
K2318892023-12-21Ultrasound Biotechnology (Shanghai) Co…Endoscopic Ultrasonic Diagnostic Equipment /Disposab…PDF
K2305112023-10-25Maui ImagingK3900 Ultrasound Imaging SystemPDF
K2324592023-09-12Sonic IncytesVelacurPDF
K2312832023-09-11Bard Access Systems, Inc. (C.R. Bard, …SiteRite™ 9 Ultrasound SystemPDF

其中 26 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: IYO
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。