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
Apr 14, 2022K220510Yushan X-Ray Flat Panel Detector with DROC
Innocare Optoelectronics Corp., TW
MQB
Apr 1, 2022K220668Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd., CN
MQB
Mar 29, 2022K213646Focus HD 35 Detector
Iray Technology Taicang , Ltd., CN
MQB
Mar 29, 2022K213529Focus HD 43 Detector
Iray Technology Taicang , Ltd., CN
MQB
Feb 16, 2022K21404414HQ901G-B
Lg Electronics.Inc, KR
MQB
Feb 4, 2022K220098Digital Radiography CXDI-Pro, Digital Radiography D1
Canon, Inc., JP
MQB
Jan 31, 2022K213908SKR 3000
Konica Minolta, Inc., JP
MQB
Jan 24, 2022K213780DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
Canon, Inc., JP
MQB
Jan 21, 2022K214030Universal DR 1748
Konica Minolta Healthcare Americas, Inc.
MQB
Jan 14, 2022K213307Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
MQB
Nov 18, 2021K213469VALORY
Agfa N.V., BE
MQB
Nov 15, 2021K213497ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
H&abyz Co., Ltd., KR
MQB
Oct 18, 2021K2127530909FCB, 1212FCA
Rayence Co., Ltd., KR
MQB
Sep 17, 2021K212269Intelligent NR
Canon, Inc., JP
MQB
Sep 9, 2021K212553DIGITAL RADIOGRAPHY CXDI-Pro, D1
Canon, Inc., JP
MQB
Aug 25, 2021K212051RFA-1717DIG, RFA-1717DIC
Astel, Inc., KR
MQB
Aug 24, 2021K210619SKR 3000
Konica Minolta, Inc., JP
MQB
Aug 23, 2021K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
Pzmedical Technology Co., Ltd., CN
MQB
Jul 30, 2021K211790DX-D Imaging Package with XD Detectors
Agfa N.V., BE
MQB
Jul 9, 2021K211542PRIMO S
A.T.S. Applicazione Tecnologie Speciali S.R.L., IT
MQB
Jun 4, 2021K211108Prudent 1717, Prudent 1417, Prudent 1212
Pixxgen Corporation, KR
MQB
Apr 30, 2021K210919AcuityDRe
Radmedix, LLC
MQB
Apr 28, 2021K2109851717FCC
Rayence Co., Ltd., KR
MQB
Apr 21, 2021K210988Yushan X-Ray Flat Panel Detector with DROC
Innocare Optoelectronics Corp., TW
MQB
Apr 2, 2021K202441Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.
MQB
Mar 24, 2021K203703I-Q View
First Source, Inc.
MQB
Mar 12, 2021K203188ADD
H&abyz Co., Ltd., KR
MQB
Mar 3, 2021K210316Mars 1417X Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd., CN
MQB
Mar 2, 2021K210314Mars1717X Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd., CN
MQB
Feb 19, 2021K202995X-ray Flat Panel Detectors/CareView 3600RF
Careray Digital Medical System Co., Ltd., CN
MQB
Jan 26, 2021K203849General Radiography CXDI-CS01
Canon, Inc., JP
MQB
Dec 2, 2020K203159Lux 35 Detector
Carestream Health
MQB
Oct 26, 2020K2027221212FCA
Rayence Co., Ltd., KR
MQB
Oct 11, 2020K201528Yushan X-Ray Flat Panel Detector with DROC
Innocare Optoelectronics Corp., TW
MQB
Sep 30, 2020K202564DigitalDiagnost C90
Philips Medical Systems Dmc GmbH, DE
MQB
Sep 3, 2020K201591Flat Panel Detector
Ka Imaging, Inc., CA
MQB
Aug 7, 2020K201932X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
Careray Digital Medical System Co., Ltd., CN
MQB
Jul 23, 2020K2017961717SCV, 1717SGV
Rayence Co., Ltd., KR
MQB
Jun 29, 2020K201503Edge Air(1417) Digital Flat Panel X-ray Detector
Osko, Inc.
MQB
Jun 10, 2020K201247Intraoral Sensor
Dentium Co., Ltd (Ict Branch), KR
MQB
May 12, 2020K201043Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
Iray Technology Taicang , Ltd., CN
MQB
May 6, 2020K201058Accuvue+
Radmedix, LLC
MQB
May 1, 2020K201004Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
Iray Technology Taicang , Ltd., CN
MQB
Apr 23, 2020K200787BSD3543W
Bontech Co., Ltd., KR
MQB
Apr 10, 2020K200668DR-ID 1200SDK System
Fujifilm Corporation, JP
MQB
Apr 1, 2020K200622Focus 43C detector, TRIMAX 43C detector
Iray Technology Taicang , Ltd., CN
MQB
Mar 18, 2020K200418VIVIX-S VW
Vieworks Co., Ltd., KR
MQB
Feb 18, 2020K192894Vita Flex CR System with LLI
Carestream Health, Inc.
MQB
Feb 14, 2020K193644E-COM DR-2000 DR
Livermoretech, Inc.
MQB
Jan 31, 2020K200018HAD1717MC
H&Abyz, KR
MQB

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