MQB · Class II · 21 CFR 892.1680

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
313–336 of 424
Cleared Oct 30, 2009
DIRECT DIGITIZER, REGIUS MODEL 210
K092717
Konica Minolta Medical & Graphic, Inc.
Radiology · 57d
Cleared Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238
Agfa Healthcare N.V.
Radiology · 19d
Cleared Jun 15, 2009
DIGITAL RADIOGRAPHY CXDI-60C
K091545
Canon, Inc.
Radiology · 19d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
K091435
Canon, Inc.
Radiology · 15d
Cleared May 29, 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
K091436
Canon, Inc.
Radiology · 15d
Cleared May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672
Agfa Healthcare N.V.
Radiology · 66d
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318
Carestream Health, Inc.
Radiology · 56d
Cleared Mar 24, 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
K090623
Canon USA, Inc.
Radiology · 15d
Cleared Mar 24, 2009
WIRELESS PORTABLE DETECTOR FD-W17
K090625
Philips Medical Systems North America Co.
Radiology · 15d
Cleared Sep 12, 2008
DRAD3000E/RADREX-I
K082494
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 24, 2008
DIGITAL RADIOGRAPHY CXDI-60G
K081648
Canon, Inc.
Radiology · 12d
Cleared Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Nov 16, 2007
DRAD-3000E, RADREX-I
K073165
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Nov 13, 2007
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
K073056
Vieworks Co., Ltd.
Radiology · 14d
Cleared May 30, 2007
DIRECT DIGITIZER, REGIUS MODEL 110
K071181
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared Jan 31, 2007
X3C DIGITAL RADIOGRAPHIC DETECTOR
K070079
Imaging Dynamics Company , Ltd.
Radiology · 22d
Cleared Nov 22, 2006
DX-SI
K063421
Agfa Corp.
Radiology · 9d
Cleared Nov 17, 2006
DEFINIUM 5000 X-RAY SYSTEM
K063283
Sedecal., Sa.
Radiology · 18d
Cleared Nov 02, 2006
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM
K063039
Imaging Dynamics Company , Ltd.
Radiology · 30d
Cleared Sep 29, 2006
XPLORER 1600 PLUS
K062586
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Aug 17, 2006
CXDI-40EC
K062221
Canon, Inc.
Radiology · 15d
Cleared May 09, 2006
AXIOM ARISTOS FX PLUS
K061054
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Mar 16, 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137
Eastman Kodak Company
Radiology · 56d
Cleared Mar 10, 2006
DIGITAL RADIOGRAPHY CXDI-50C
K060433
Canon, Inc.
Radiology · 17d