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Panels › Radiology › Product code MQB · Class 2

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

Regulation 892.1680

3510(k)s in 12 months (424 all time)
2recalls in 12 months (195 all time)
193recalls that name a 510(k)
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Top companies in MQB

Company510(k)sRecalls
GE Healthcare047
Philips Medical Systems Dmc GmbH930
Canon USA, Inc.331
Rayence Co., Ltd.290
Ge Medical Systems, LLC221
DRTECH Corporation180
Carestream Health152
Iray Technology Taicang , Ltd.170
Siemens Medical Solutions USA, Inc.215
Agfa Corp.78
Decided510(k)Device and applicantCode
Aug 25, 2017K171716SKR 3000
Konica Minolta, Inc., JP
MQB
Jul 7, 2017K171461SkyPlate Detector for Philips Radiography/Fluoroscopy Systems
Philips Medical Systems Dmc GmbH, DE
MQB
Jul 7, 2017K170480Models 3543A, 4343A, 2929A and A843B
Shanghai PZ Medical Technolgoy Co., Ltd., CN
MQB
Jun 30, 2017K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Fujifilm Medical Systems U.S.A, Inc.
MQB
Jun 21, 2017K171485BSD4343R Digital Flat Panel X-ray Detector
Bontech, Inc., KR
MQB
Jun 12, 2017K1714181417WCC_127um and1417WCC_140um
Rayence Co., Ltd., KR
MQB
Jun 12, 2017K1714171417WGC_127um and 1417WGC_140um
Rayence Co., Ltd., KR
MQB
Jun 9, 2017K1714201717SCC_127um and 1717SCC_140um
Rayence Co., Ltd., KR
MQB
Jun 9, 2017K1714191717SGC_127um and 1717SGC_140um
Rayence Co., Ltd., KR
MQB
May 17, 2017K171138Nexus DR Digital X-ray Imaging System
Varex Imaging Corporation
MQB
May 15, 2017K171137EVS 2430W, EVS 2430GW
DRTECH Corporation, KR
MQB
May 11, 2017K171085GMR40
Neurologica Corporation, A Subsidiary OF
MQB
May 1, 2017K170975Televere Digital Imaging System
Televere Systems
MQB
Mar 21, 2017K163157SmartGrid
Carestream Health
MQB
Mar 1, 2017K170332DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
Canon, Inc., JP
MQB
Feb 22, 2017K170202Aquarius 8600
Imaging Dynamics Company , Ltd., CA
MQB
Feb 9, 2017K170113pixium 4343RCE
Philips Medical Systems Dmc GmbH, DE
MQB
Feb 8, 2017K163703VIVIX-S 1417N
Vieworks Co., Ltd., KR
MQB
Jan 27, 2017K162909CSX-30 Flat Panel Detector
Canon, Inc. – Medical Equipment Group, JP
MQB
Dec 21, 2016K162555EVS 4343, EVS 4343G
DRTECH Corporation, KR
MQB
Dec 20, 2016K162344INNOLUX RIC
Innolux Corporation, TW
MQB
Dec 8, 2016K161730Wireless Digital Flat Panel Detector
Iray Technology (Shanghai) , Ltd., CN
MQB
Dec 2, 2016K162552EVS 3643, EVS 3643G
DRTECH Corporation, KR
MQB
Dec 1, 2016K163019CareView 750Cw/750C X-ray Flat Panel Detectors
Careray Digital Medical System Co., Ltd., CN
MQB
Oct 28, 2016K160143ClearVision ExamVue Flat Panel Detector
Jpi Healthcare, Inc., KR
MQB
Oct 14, 2016K162487BSD3543 Digital Flat Panel X-ray Detector
Bontech, Inc., KR
MQB
Oct 6, 2016K1625191717WCC / 1717WGC
Rayence Co., Ltd., KR
MQB
Oct 6, 2016K1625181012WCC, 1012WGC
Rayence Co., Ltd., KR
MQB
Oct 3, 2016K162504SKR 3000
Konica Minolta, Inc., JP
MQB
Sep 22, 2016K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
Agfa Healthcare N.V., BE
MQB
Sep 8, 2016K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
Perkinelmer, Inc.
MQB
Sep 6, 2016K161459Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Varian Medical Systems, X-Ray Products-Infimed
MQB
Sep 1, 2016K162178CareView 1500P X-ray Flat Panel Detectors
Careray Digital Medical System Co., Ltd., CN
MQB
Sep 1, 2016K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
Perkinelmer, Inc.
MQB
Jun 28, 2016K153312SCATTER CORRECTION FOR CXDI SERIES
Canon, Inc., JP
MQB
Jun 9, 2016K160204BSD4343 Digital Flat Panel X-ray Detector
Bontech, Inc., KR
MQB
May 20, 2016K160810ViZion DR + Wireless
Viztek, LLC
MQB
Apr 8, 2016K153464FDR D-EVO flat Panel Detector System
Fujifilm Medical Systems U.S.A, Inc.
MQB
Mar 18, 2016K153710Tuxedo Digital Dental Sensor
Led Dental, Inc., CA
MQB
Feb 26, 2016K152894VIVIX-S 1717N
Vieworks Co., Ltd., KR
MQB
Feb 26, 2016K152855VIVIX-S 1012N
Vieworks Co., Ltd., KR
MQB
Dec 24, 2015K153492CareView 1800L
Careray Digital Medical System Co., Ltd., CN
MQB
Dec 22, 2015K153318Philips Eleva Workspot with SkyFlow
Philips Medical Systems Dmc GmbH, DE
MQB
Dec 21, 2015K153401GR40CW
Samsung Electronics Co., Ltd., KR
MQB
Dec 11, 2015K152639DR 600
Agfa Healthcare N.V., BE
MQB
Nov 25, 2015K153142Carestream DRX-1 System with DRX Plus 4343 Detectors
Carestream Health, Inc.
MQB
Nov 10, 2015K153058CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
Careray Digital Medical System Co., Ltd., CN
MQB
Nov 10, 2015K152151ATAL 9
Atlaim Corporation, KR
MQB
Nov 5, 2015K152138FDR D-EVO GL Flat Panel Detector System
Fujifilm Medical System U.S.A., Inc.
MQB
Oct 21, 2015K151942EVS 3643
DRTECH Corporation, KR
MQB

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