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
337–360 of 424
Cleared Feb 24, 2009
RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
K083645
5 Star Medical, Inc.
Radiology · 77d
Cleared Nov 18, 2008
DIGITAL RADIOGRAPHY, FLEXDR C30
K082347
Konica Minolta Technoproduct Co., Ltd.
Radiology · 95d
Cleared Sep 12, 2008
DRAD3000E/RADREX-I
K082494
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963
Agfa Healthcare Corporation
Radiology · 15d
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 Jun 11, 2008
SATURN 9000-810
K080589
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
K073670
Orex Computed Radiography, Ltd.
Radiology · 29d
Cleared Jan 23, 2008
FLAATZ 750
K080064
Drtech Corp.
Radiology · 13d
Cleared Nov 16, 2007
DRAD-3000E, RADREX-I
K073165
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Nov 14, 2007
SATURN 9000-550
K072984
New Medical Co., Ltd.
Radiology · 22d
Cleared Nov 13, 2007
SATURN 9000-750
K072983
New Medical Co., Ltd.
Radiology · 21d
Cleared Nov 13, 2007
DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
K073056
Vieworks Co., Ltd.
Radiology · 14d
Cleared Aug 15, 2007
CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
K071682
Alara, Inc.
Radiology · 57d
Cleared Jul 16, 2007
SATURN 9000
K063710
New Medical Co., Ltd.
Radiology · 214d
Cleared May 30, 2007
DIRECT DIGITIZER, REGIUS MODEL 110
K071181
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared May 30, 2007
VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS
K071193
Vidar Systems Corp.
Radiology · 30d
Cleared May 09, 2007
SYNEPIX 4600 DETECTOR
K070829
Analogic Corporation
Radiology · 44d
Cleared May 08, 2007
AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
K071162
Agfa Healthcare Corp.
Radiology · 12d
Cleared Mar 16, 2007
VIDAR VISION 2000
K070563
Vidar Systems Corp.
Radiology · 17d
Cleared Mar 09, 2007
PHILIPS ESSENTA DR
K070528
Philips Medical Systems GmbH, Dmc
Radiology · 14d
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