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MQB

Solid State X-Ray Imager (Flat Panel/Digital Imager)

产品代码
MQB
器械名称
Solid State X-Ray Imager (Flat Panel/Digital Imager)
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 892.1680
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)
20 件
其中 Summary 已存档
18 份,可直接下载
FDA 历史累计 510(k)
424 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)(20 件)

数据窗口为最近三年。最新一件:2026-07-31。

510(k) 号批准日期申请人器械名称摘要
K2538002026-07-31Rayence Co., Ltd.0909FCE, 0909FCE-HSPDF
K2608202026-06-18Vieworks Co., Ltd.VIVIX-S 4386W (FXRD-4386WA)PDF
K2529962026-06-12Konica Minolta Healthcare Americas, In…Universal 1417PIPDF
K2529112025-10-09Iray Imaging Technology (Haining) Limi…Lux HD 2530 detector (Lux HD 2530)PDF
K2502112025-07-22Innocare Optoelectronics Corp.Yushan X-Ray Flat Panel DetectorPDF
K2506652025-06-17Konica Minolta, Inc.SKR 3000PDF
K2437342025-04-18Allengers Medical Systems LimitedWireless/ Wired X-Ray Flat Panel DetectorsPDF
K2427702025-03-20DRTECH CorporationEXPD 114; EXPD 114G; EXPD 114P; EXPD 114PGFDA
K2434432025-03-19DRTECH CorporationEXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; E…PDF
K2435562025-03-18Iray Imaging Technology (Haining) Limi…Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (…FDA
K2440102025-02-24Jpi Healthcare Co, Ltd.ExamVue ApexPDF
K2431712024-12-19Innocare Optoelectronics Corp.Yushan X-Ray Flat Panel DetectorPDF
K2413192024-11-21Konica Minolta, Inc.SKR 3000PDF
K2411252024-11-15Vieworks Co., Ltd.VIVIX-S 1751SPDF
K2407712024-11-12Prognosys Medical Systems Private Limi…PRORAD X-Ray Flat Panel Detector with DROCPDF
K2413462024-11-07Aspen Imaging Healthcare, Inc.IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Pan…PDF
K2423942024-09-09Rayence Co., Ltd.Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-…PDF
K2403712024-03-07Rayence Co., Ltd.0909FCC, 0909FCC-HSPDF
K2320822024-02-13DRTECH CorporationEXPD 4343SPDF
K2327532023-11-16DRTECH CorporationEXPD 4343D; EXPD 3643DPDF

其中 18 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: MQB
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。