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
Cleared
Oct 06, 2016
1717WCC / 1717WGC
Rayence Co., Ltd.
Radiology
27d
Cleared
Jun 28, 2016
SCATTER CORRECTION FOR CXDI SERIES
Canon, Inc.
Radiology
224d
Cleared
Apr 08, 2016
FDR D-EVO flat Panel Detector System
Fujifilm Medical Systems U.S.A, Inc.
Radiology
129d
Cleared
Dec 21, 2015
GR40CW
Samsung Electronics Co., Ltd.
Radiology
27d
Cleared
Nov 25, 2015
Carestream DRX-1 System with DRX Plus 4343 Detectors
Carestream Health, Inc.
Radiology
26d
Cleared
Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
Fujifilm Medical System U.S.A., Inc.
Radiology
97d
Cleared
Oct 16, 2015
GR40CW
Samsung Electronics Co., Ltd.
Radiology
80d
Cleared
Jun 24, 2015
Carestream DRX-1 System
Carestream Health, Inc.
Radiology
92d
Cleared
Mar 27, 2015
1717SGN / 1717SCN Digital Flat Panel X-ray Detector
Rayence Co., Ltd.
Radiology
63d
Cleared
Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
Fujifilm Medical System U.S.A., Inc.
Radiology
90d
Cleared
Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
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
Rayence Co., Ltd.
Radiology
34d
Cleared
Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
Rayence Co., Ltd.
Radiology
34d
Cleared
Jul 01, 2014
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
Canon, Inc.
Radiology
210d
Cleared
May 15, 2014
XGEO GR40CW
Samsung Electronics Co., Ltd.
Radiology
105d
Cleared
May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR
Rayence Co., Ltd.
Radiology
123d
Cleared
May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
Rayence Co., Ltd.
Radiology
123d
Cleared
Apr 11, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
Rayence Co., Ltd.
Radiology
29d
Cleared
Mar 11, 2014
BONE SUPPRESSION SOFTWARE
Carestream Health, Inc.
Radiology
119d
Cleared
Feb 21, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR/ 910SGA
Rayence Co., Ltd.
Radiology
106d
Cleared
Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
Fujifilm Medical Systems U.S.A, Inc.
Radiology
105d
Cleared
Sep 17, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
Rayence Co., Ltd.
Radiology
148d
Cleared
Jul 03, 2013
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
Canon, Inc.
Radiology
75d
Cleared
Jul 02, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
Rayence Co., Ltd.
Radiology
89d