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
Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
Carestream Health, Inc.
Radiology
99d
Cleared
Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
Carestream Health, Inc.
Radiology
105d
Cleared
Mar 12, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
Rayence Co., Ltd.
Radiology
132d
Cleared
Jan 30, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
Rayence Co., Ltd.
Radiology
128d
Cleared
Jan 01, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
Rayence Co., Ltd.
Radiology
99d
Cleared
Oct 19, 2012
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
Rayence Co., Ltd.
Radiology
88d
Cleared
Oct 09, 2012
RADREX-I, SW V4.00 MODEL DRAD-3000E
Toshiba America Medical Systems, In.C
Radiology
22d
Cleared
Aug 28, 2012
FDR GO FLEX
Fujifilm Medical System U.S.A., Inc.
Radiology
180d
Cleared
Aug 16, 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
Rayence Co., Ltd.
Radiology
24d
Cleared
Dec 29, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
Rayence Co., Ltd.
Radiology
21d
Cleared
Nov 22, 2011
INFINIX-CCI
Toshiba America Medical Systems, In.C
Radiology
40d
Cleared
Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
Fujifilm Medical System U.S.A., Inc.
Radiology
92d
Cleared
Aug 30, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
Fujifilm Medical System U.S.A., Inc.
Radiology
88d
Cleared
Mar 29, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
Fujifilm Medical Systems U.S.A, Inc.
Radiology
111d
Cleared
Nov 29, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR
VATECH Co., Ltd.
Radiology
175d
Cleared
Nov 18, 2010
WIRELESS DR IMAGING OPTION-WDR1
Ge Medical Systems, LLC
Radiology
70d
Cleared
Jul 15, 2010
FLAT PANEL DETECTOR, MODEL FDR D-EVO
Fujifilm Medical Systems U.S.A, Inc.
Radiology
120d
Cleared
Jan 21, 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
Fujifilm Medical System U.S.A., Inc.
Radiology
79d
Cleared
Jun 15, 2009
DIGITAL RADIOGRAPHY CXDI-60C
Canon, Inc.
Radiology
19d
Cleared
May 29, 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
Canon, Inc.
Radiology
15d
Cleared
May 29, 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
Canon, Inc.
Radiology
15d
Cleared
Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
Carestream Health, Inc.
Radiology
56d
Cleared
Mar 24, 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
Canon USA, Inc.
Radiology
15d
Cleared
Sep 12, 2008
DRAD3000E/RADREX-I
Toshiba America Medical Systems, In.C
Radiology
14d