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IZL

System, X-Ray, Mobile

产品代码
IZL
器械名称
System, X-Ray, Mobile
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 892.1720
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)
25 件
其中 Summary 已存档
23 份,可直接下载
FDA 历史累计 510(k)
237 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)(25 件)

数据窗口为最近三年。最新一件:2026-08-03。

510(k) 号批准日期申请人器械名称摘要
K2602362026-08-03GEMSS HEALTHCARE CO., LTD.XLITEFDA
K2530582026-06-18Shantou Institute of Ultrasonic Instru…Portable DR Imaging SystemPDF
K2600852026-05-14DRGEM CorporationRAYMO Mobile X-ray System (Model: RAYMO)PDF
K2531852026-03-11Carestream HealthLux HD Detectors, DRX-LC Detector, DRX-Revolution Mo…PDF
K2532442026-02-23Poskom Co., Ltd.AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, A…PDF
K2509762025-12-19Poskom Co., Ltd.Airbile-100PDF
K2517102025-10-24Solutions For Tomorrow ABMobile X-ray unit (!M1)PDF
K2438642025-09-12Bontech Co., Ltd.BONX805PDF
K2514432025-08-22DRGEM CorporationPROMOPDF
K2512232025-08-04H&abyz Co., Ltd.HnX-P1, HnX-PBPDF
K2505972025-07-31Remedi, Inc.REMEX Xcam6PDF
K2434732025-07-29Prognosys Medical Systems Private Limi…PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTAB…PDF
K2507502025-07-18Dk Medical Systems Co., Ltd.INNOVISION-P5PDF
K2440492025-05-28Livermoretech, Inc.Europa (Alternative: AiRTouch) portable X-ray systemPDF
K2419802025-05-06Solutions For Tomorrow AB!M1PDF
K2419962025-04-18Ecoray Co., Ltd.ULTRA 1040PDF
K2420152024-12-16DRGEM CorporationTOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ…PDF
K2415052024-12-10Carestream Health, Inc.DRX-Revolution Mobile X-ray SystemPDF
K2408412024-12-09Shenzhen Browiner Tech Co., Ltd.Digital Radiography System (ManntiX B, ManntiX K)PDF
K2425152024-10-10Shanghai United Imaging Healthcare Co.…uDR 380i ProPDF
K2426512024-10-01Samsung Electronics Co., Ltd.GM85PDF
K2341082024-09-20Energy Resources International Co., Lt…ERI Portable X-ray System (CVX-air); ERI Portable X-…PDF
K2400092024-07-03First Source, Inc.iQFlex ProPDF
K2402842024-03-28Shenzhen Browiner Tech Co., Ltd.Digital Radiography System (MobileApex 60E, MobileAp…PDF
K2336782024-02-14Philips Medical Systems Dmc GmbHRadiography 7000 MFDA

其中 23 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: IZL
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。