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
Nov 22, 2011
INFINIX-CCI
Toshiba America Medical Systems, In.C
Radiology
40d
Cleared
Nov 18, 2011
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
Medicatech USA
Radiology
115d
Cleared
Nov 10, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
Samsung Mobile Display Co., Ltd.
Radiology
69d
Cleared
Oct 20, 2011
DIGIVIEW 250
Kub Technologies, Inc.
Radiology
339d
Cleared
Oct 20, 2011
VIZION DR
Viztek, LLC
Radiology
37d
Cleared
Oct 04, 2011
FLAATZ 560
Drtech Corp.
Radiology
119d
Cleared
Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
Fujifilm Medical System U.S.A., Inc.
Radiology
92d
Cleared
Sep 02, 2011
DIGITAL RADIOGRAPHY
Canon Inc. -Medical Equipment Group
Radiology
79d
Cleared
Sep 02, 2011
DIGITAL RADIOGRAPHY
Canon Inc. -Medical Equipment Group
Radiology
22d
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
Aug 02, 2011
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
Direct Digital Imaging Technology (Beijing), Inc.
Radiology
132d
Cleared
Jul 13, 2011
SANTEVIEW
Sehyun Co., Ltd.
Radiology
64d
Cleared
Jun 02, 2011
REGUIS SIGMA
Konica Minolta Medical & Graphic, Inc.
Radiology
164d
Cleared
May 27, 2011
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
Imaging Dynamics Company , Ltd.
Radiology
37d
Cleared
Apr 27, 2011
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
Meridian Medical Systems, LLC
Radiology
140d
Cleared
Apr 20, 2011
SATURN 8000-GS
New Medical Co., Ltd.
Radiology
85d
Cleared
Mar 29, 2011
DIGITAL RADIOGRAPHY
Canon Inc. -Medical Equipment Group
Radiology
112d
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
Aug 03, 2010
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
Air Techniques, Inc.
Radiology
88d
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
Nov 06, 2009
DX-D IMAGING PACKAGE
Agfa Healthcare N.V.
Radiology
67d