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 30, 2009
DIRECT DIGITIZER, REGIUS MODEL 210
Konica Minolta Medical & Graphic, Inc.
Radiology
57d
Cleared
Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
Agfa Healthcare N.V.
Radiology
19d
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
May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
Agfa Healthcare N.V.
Radiology
66d
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
Mar 24, 2009
WIRELESS PORTABLE DETECTOR FD-W17
Philips Medical Systems North America Co.
Radiology
15d
Cleared
Sep 12, 2008
DRAD3000E/RADREX-I
Toshiba America Medical Systems, In.C
Radiology
14d
Cleared
Jun 24, 2008
DIGITAL RADIOGRAPHY CXDI-60G
Canon, Inc.
Radiology
12d
Cleared
Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
Toshiba America Medical Systems, In.C
Radiology
13d
Cleared
Nov 16, 2007
DRAD-3000E, RADREX-I
Toshiba America Medical Systems, In.C
Radiology
7d
Cleared
Nov 13, 2007
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
Vieworks Co., Ltd.
Radiology
14d
Cleared
May 30, 2007
DIRECT DIGITIZER, REGIUS MODEL 110
Konica Minolta Medical & Graphic, Inc.
Radiology
30d
Cleared
Jan 31, 2007
X3C DIGITAL RADIOGRAPHIC DETECTOR
Imaging Dynamics Company , Ltd.
Radiology
22d
Cleared
Nov 22, 2006
DX-SI
Agfa Corp.
Radiology
9d
Cleared
Nov 17, 2006
DEFINIUM 5000 X-RAY SYSTEM
Sedecal., Sa.
Radiology
18d
Cleared
Nov 02, 2006
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
Imaging Dynamics Company , Ltd.
Radiology
30d
Cleared
Sep 29, 2006
XPLORER 1600 PLUS
Imaging Dynamics Company , Ltd.
Radiology
28d
Cleared
Aug 17, 2006
CXDI-40EC
Canon, Inc.
Radiology
15d
Cleared
May 09, 2006
AXIOM ARISTOS FX PLUS
Siemens Medical Solutions USA, Inc.
Radiology
22d
Cleared
Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
Eastman Kodak Company
Radiology
56d
Cleared
Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
Canon, Inc.
Radiology
17d