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OWB

Interventional Fluoroscopic X-Ray System

产品代码
OWB
器械名称
Interventional Fluoroscopic X-Ray System
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 892.1650
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)
325 件

FDA 分类定义

Interventional fluoroscopy

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（57 件）

数据窗口为最近三年。最新一件：2026-08-21。

510(k) 号批准日期申请人器械名称
K2537262026-08-21Shanghai United Imaging Healthcare Co.uAngio AVIVA CX 摘要
K2614132026-08-19DRTECH CorporationEXTRON 3;EXTRON 6 摘要
K2542052026-08-07Philips Medical Systems Nederland B.V.Zenition 30 摘要
K2606072026-07-31Radiaction , Ltd.Shield System (Siemens 30x40) 摘要
K2536702026-07-10Philips Medical Systems B.V.SmartCT (R3.0 (L10)) 摘要
K2527352026-05-22Pulmera, Inc.C-beam 摘要
K2525032026-04-30Canon, Inc.Intelligent NR 摘要
K2541732026-04-24Siemens Medical Solutions USA, Inc.ARTIS icono floor; ARTIS icono biplane; ARTIS icono 摘要
K2537522026-04-23Siemens Medical Solutions USA, Inc.ARTIS genio floor; ARTIS icono.explore floor 摘要
K2522292026-04-02Genoray Co., Ltd.BELLIGER ACE 摘要
K2520992026-03-24Shimadzu CorporationTrinias 摘要
K2535842026-03-10Canon Medical Systems CorporationAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvo 摘要
K2525002026-02-20Cara Medical, Ltd.CARA System 摘要
K2519922026-02-11Savfe Co. , Ltd.ArmSure Fluoroscopic Positioning System 摘要
K2541862026-01-16Philips Medical Systems B.V.Azurion R3.1 摘要
K2520682025-12-22Oxos MedicalMC2 Portable X-ray System 摘要
K2518932025-12-16Skanray Technologies LimitedSKAN C PULSAR 摘要
K2511992025-12-09GE Medical Systems SCSAllia Moveo 摘要
K2502412025-11-04Siemens Medical Solutions USA, Inc.Cios Select 摘要
K2518272025-10-24Philips Medical Systems B.V.Azurion R3.1 摘要
K2516022025-10-10Canon Medical Systems CorporationAlphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvo 摘要
K2515232025-07-29Siemens Medical Solutions USA, Inc.Cios Spin 摘要
K2434322025-07-22Brainlab AGVascular Navigation PAD 2.0; Navigation Software Vas 摘要
K2506602025-07-14Siemens Medical SolutionsLUMINOS Q.namix T; LUMINOS Q.namix R 摘要
K2515202025-07-09Siemens Medical Solutions USA, Inc.Cios Alpha; Cios Flow 摘要
K2438842025-07-07Caranx MedicalTAVIPILOT 摘要
K2500102025-06-10DRTECH CorporationEXTRON 3; EXTRON 5; EXTRON 7 摘要
K2434112025-05-19Nanjing Perlove Medical Equipment Co.,Diagnostic X-ray System 摘要
K2427312025-05-16Medicatech USA, Inc.MasteRad MiniX Mobile Digital Imaging System (Mini-X 摘要
K2502822025-04-30A.T.S. Applicazione Tecnologie SpecialPersona C HR 摘要
K2433762025-04-28Shanghai United Imaging Healthcare Co.uAngio AVIVA CX 摘要
K2340672025-03-28Medphoton GmbHImagingRing m (Version 2.0); Loop-X (Version 2.0); L 摘要
K2436462025-03-17Ziehm Imaging GmbHZiehm Solo FD 摘要
K2437352025-03-13Ziehm Imaging GmbHZiehm Vision FD 摘要
K2434462025-02-25GE Medical Systems SCS3DXR 摘要
K2433032025-01-21Ziehm Imaging GmbHZiehm Vision RFD 3D 摘要
K2433282025-01-15Ziehm Imaging GmbHZiehm Vision RFD 摘要
K2415672024-12-06Oxos MedicalMC2 Portable X-ray System 摘要
K2415722024-10-22Siemens Medical Solutions USA, Inc.ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (bi 摘要
K2331072024-08-30Canon Medical Systems CorporationAlphenix, INFX-8000V/B, INFX-8000V/S, V9.5 摘要
K2332302024-06-21Epica International, Inc.See Factor CT3™ 摘要
K2404652024-06-21Medtronic Navigation, Inc.O-arm O2 Imaging System 摘要
K2401992024-05-22Alphatec Spine, Inc.IntraOp Alignment System 摘要
K2402242024-05-22Philips Medical Systems Nederlands B.VZenition 90 摘要
K2322982024-04-26Canon, Inc.DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl 摘要
K2337482024-03-15Siemens Medical Solutions USA, Inc.CIARTIC Move (VB10) 摘要
K2324202024-02-16Philips Medical Systems Nederland B.V.Zenition 30 摘要
K2400992024-02-05Ziehm Imaging GmbHZiehm Vision RFD 摘要
K2400202024-01-30Ziehm Imaging GmbHZiehm Vision FD 摘要
K2341092024-01-26Ziehm Imaging GmbHZiehm Solo FD 摘要
K2317002023-12-15Ziehm Imaging GmbHZiehm Vision FD 摘要
K2309492023-12-15Siemens Medical Solutions USA, Inc.ARTIS pheno (VE30A) 摘要
K2309502023-12-14Siemens Medical Solutions USA, Inc.ARTIS icono (VE30A) 摘要
K2316692023-12-12Ziehm Imaging GmbHZiehm Solo FD 摘要
K2316922023-11-20Ziehm Imaging GmbHZiehm Vision RFD 摘要
K2332002023-11-16GEMSS HEALTHCARE CO., LTD.XPLUS 35 Series (XPLUS 35, XPLUS 35FD) 摘要
K2323442023-10-11GE Medical Systems SCSAllia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 O 摘要
FDA 官方分类页： OWB
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。