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 23, 2011
SDX-4343CS
Samsung Mobile Display Co., Ltd.
Radiology
63d
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
ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
Alara, Inc.
Radiology
276d
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
May 13, 2011
COMPUTED RADDIOGRAPHY SCANNER
3Disc Americas
Radiology
242d
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
Mar 04, 2011
FLAATZ 750E
Drtech Corp.
Radiology
186d
Cleared
Feb 11, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
Samsung Mobile Display Co., Ltd.
Radiology
178d
Cleared
Dec 21, 2010
STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
Comed Co., Ltd.
Radiology
284d