MQB · Class II · 21 CFR 892.1680

FDA Product Code MQB: Solid State X-ray Imager (flat Panel/digital Imager)

FDA product code MQB covers solid-state X-ray imagers, also known as flat panel detectors or digital image receptors.

These devices replace traditional film and computed radiography cassettes with direct digital capture of X-ray images. They provide higher image quality, lower radiation dose, and immediate image availability compared to conventional systems.

MQB devices are Class II medical devices, regulated under 21 CFR 892.1680 and reviewed by the FDA Radiology panel.

Leading manufacturers include Rayence Co., Ltd., Canon, Inc. and Iray Technology Taicang , Ltd..

424
Total
424
Cleared
81d
Avg days
1997
Since
424 devices
145–168 of 424
Cleared Oct 06, 2016
1717WCC / 1717WGC
K162519
Rayence Co., Ltd.
Radiology · 27d
Cleared Jun 28, 2016
SCATTER CORRECTION FOR CXDI SERIES
K153312
Canon, Inc.
Radiology · 224d
Cleared Apr 08, 2016
FDR D-EVO flat Panel Detector System
K153464
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 129d
Cleared Dec 21, 2015
GR40CW
K153401
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
K153142
Carestream Health, Inc.
Radiology · 26d
Cleared Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
K152138
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared Oct 16, 2015
GR40CW
K152094
Samsung Electronics Co., Ltd.
Radiology · 80d
Cleared Jun 24, 2015
Carestream DRX-1 System
K150766
Carestream Health, Inc.
Radiology · 92d
Cleared Mar 27, 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
K150150
Rayence Co., Ltd.
Radiology · 63d
Cleared Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K142003
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 94d
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
K141563
Rayence Co., Ltd.
Radiology · 34d
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
K141566
Rayence Co., Ltd.
Radiology · 34d
Cleared Jul 01, 2014
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
K133693
Canon, Inc.
Radiology · 210d
Cleared May 15, 2014
XGEO GR40CW
K140235
Samsung Electronics Co., Ltd.
Radiology · 105d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR
K140056
Rayence Co., Ltd.
Radiology · 123d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
K140060
Rayence Co., Ltd.
Radiology · 123d
Cleared Apr 11, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
K140646
Rayence Co., Ltd.
Radiology · 29d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442
Carestream Health, Inc.
Radiology · 119d
Cleared Feb 21, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
K133409
Rayence Co., Ltd.
Radiology · 106d
Cleared Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 105d
Cleared Sep 17, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
K131114
Rayence Co., Ltd.
Radiology · 148d
Cleared Jul 03, 2013
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
K131106
Canon, Inc.
Radiology · 75d
Cleared Jul 02, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K130935
Rayence Co., Ltd.
Radiology · 89d