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
Feb 24, 2009
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
5 Star Medical, Inc.
Radiology
77d
Cleared
Nov 18, 2008
DIGITAL RADIOGRAPHY, FLEXDR C30
Konica Minolta Technoproduct Co., Ltd.
Radiology
95d
Cleared
Sep 12, 2008
DRAD3000E/RADREX-I
Toshiba America Medical Systems, In.C
Radiology
14d
Cleared
Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
Agfa Healthcare Corporation
Radiology
15d
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
Jun 11, 2008
SATURN 9000-810
New Medical Co., Ltd.
Radiology
100d
Cleared
Jan 25, 2008
KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
Orex Computed Radiography, Ltd.
Radiology
29d
Cleared
Jan 23, 2008
FLAATZ 750
Drtech Corp.
Radiology
13d
Cleared
Nov 16, 2007
DRAD-3000E, RADREX-I
Toshiba America Medical Systems, In.C
Radiology
7d
Cleared
Nov 14, 2007
SATURN 9000-550
New Medical Co., Ltd.
Radiology
22d
Cleared
Nov 13, 2007
SATURN 9000-750
New Medical Co., Ltd.
Radiology
21d
Cleared
Nov 13, 2007
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
Vieworks Co., Ltd.
Radiology
14d
Cleared
Aug 15, 2007
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
Alara, Inc.
Radiology
57d
Cleared
Jul 16, 2007
SATURN 9000
New Medical Co., Ltd.
Radiology
214d
Cleared
May 30, 2007
DIRECT DIGITIZER, REGIUS MODEL 110
Konica Minolta Medical & Graphic, Inc.
Radiology
30d
Cleared
May 30, 2007
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
Vidar Systems Corp.
Radiology
30d
Cleared
May 09, 2007
SYNEPIX 4600 DETECTOR
Analogic Corporation
Radiology
44d
Cleared
May 08, 2007
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
Agfa Healthcare Corp.
Radiology
12d
Cleared
Mar 16, 2007
VIDAR VISION 2000
Vidar Systems Corp.
Radiology
17d
Cleared
Mar 09, 2007
PHILIPS ESSENTA DR
Philips Medical Systems GmbH, Dmc
Radiology
14d
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