ClearanceBrief
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
Dec 20, 2019K193238Nexus DR Digital X-Ray Imaging System (with vSharp)
Varex Imaging Corporation
MQB
Dec 13, 2019K193173CareView 1800Le
Careray Digital Medical System Co., Ltd., CN
MQB
Nov 22, 2019K193031EXPD 4343P, EXPD 3643P
DRTECH Corporation, KR
MQB
Nov 22, 2019K193017EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP
DRTECH Corporation, KR
MQB
Nov 12, 2019K192932FDR D-EVO III flat panel detector system
Fujifilm Corporation, JP
MQB
Nov 7, 2019K192632DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless
Canon, Inc., JP
MQB
Nov 1, 2019K192440FDR SE Lite
Fujifilm Corporation, JP
MQB
Oct 16, 2019K192512Focus 35C Detector, Trimax 35C Detector
Iray Technology Taicang , Ltd., CN
MQB
Oct 3, 2019K192400EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
DRTECH Corporation, KR
MQB
Aug 29, 2019K191939Yushan X-Ray Flat Panel Detector
Innocare Optoelectronics Corp., TW
MQB
Aug 16, 2019K191645SKR 4000
Konica Minolta, Inc., JP
MQB
Apr 8, 2019K190611VIVIX-S 1751S
Vieworks Co., Ltd., KR
MQB
Apr 4, 2019K190691Pixx2430 Digital Diagnostic X-Ray Receptor Panel
Pixxgen Corporation, KR
MQB
Mar 13, 2019K190368Enhanced Feature Software Pack CXDI Series
Canon, Inc., JP
MQB
Mar 13, 2019K190311BIOK7600 Flat Panel Detector
Biokinemetrics, Inc.
MQB
Mar 13, 2019K190300BIOK7600W Wireless Flat Panel Detector
Biokinemetrics, Inc.
MQB
Mar 8, 2019K190146Nexus DR Digital X-ray Imaging System
Varex Imaging Corporation
MQB
Feb 8, 2019K183245Carestream DRX-1 System with DRX Plus 2530 Detectors
Carestream Health, Inc.
MQB
Jan 16, 2019K183474Carestream DRX-1 System with DRX Core Detectors
Carestream Health, Inc.
MQB
Jan 11, 2019K182973DigitalDiagnost C90
Philips Medical Systems Dmc GmbH, DE
MQB
Jan 9, 2019K183713Wireless Digital Flat Detector
Iray Technology Taicang , Ltd., CN
MQB
Jan 9, 2019K183422Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd., CN
MQB
Dec 18, 2018K182688SKR 3000
Konica Minolta, Inc., JP
MQB
Dec 7, 2018K18328617HK701G-W
Lg Electronics.Inc, KR
MQB
Dec 7, 2018K183212Nexus DR Digital X-ray Imaging System with stitching
Varex Imaging Corporation
MQB
Oct 18, 2018K18234814HK701G-W
Lg Electronics.Inc, KR
MQB
Oct 17, 2018K182551Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd., CN
MQB
Oct 17, 2018K182550Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd., CN
MQB
Oct 4, 2018K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
Pixxgen Corporation, KR
MQB
Jul 20, 2018K181631GR40CW
Samsung Electronics Co., Ltd., KR
MQB
Jul 13, 2018K181565Aquarius 8600 Digital Radiography Sensor
Biokinemetrics, Inc.
MQB
Jul 3, 2018K181526XRpad2 4343 HWC-M Flat Panel Detector
Varex Imaging Corporation
MQB
Jun 21, 2018K180809Eclipse II
Carestream Health, Inc.
MQB
Jun 13, 2018K180989PEDRA-17F Digital Flat Panel X-ray Detector
Radisen, Inc., KR
MQB
Jun 8, 2018K18033217HK700G-W
Lg Electronics, KR
MQB
May 24, 2018K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
Pixxgen Corporation, KR
MQB
May 15, 2018K181003VIVIX-S 1717V
Vieworks Co., Ltd., KR
MQB
Apr 13, 2018K180667SmartGrid
Carestream Health, Inc.
MQB
Nov 17, 2017K171270DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
Canon, Inc., JP
MQB
Nov 9, 2017K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
Imaging Dynamics Company , Ltd., CA
MQB
Nov 9, 2017K172124Televere Podiatry Digital Imaging System
Televere Systems
MQB
Oct 24, 2017K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
Varex Imaging Corporation
MQB
Oct 13, 2017K172784DX-D Imaging Package
Agfa Healthcare N.V., BE
MQB
Oct 13, 2017K172435Galaxy R Digital Radiography Upgrade
Medien International Co, Ltd., KR
MQB
Oct 12, 2017K172793SKR 3000
Konica Minolta, Inc., JP
MQB
Oct 12, 2017K171169Aquarius 8600 1417TG and Aquarius 8600 1717TG
Imaging Dynamics Company , Ltd., CA
MQB
Oct 6, 2017K172682Edge Digital Flat Panel X-ray Detector
Osko, Inc.
MQB
Oct 6, 2017K172681Edge Air Digital Flat Panel X-ray Detector
Osko, Inc.
MQB
Oct 5, 2017K171175Aquarius 8600 1417WC
Imaging Dynamics Company , Ltd., CA
MQB
Sep 26, 2017K172581CareView 1800Cw X-ray Flat Panel Detectors
Careray Digital Medical System Co., Ltd., CN
MQB

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