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
289–312 of 424
Cleared Nov 22, 2011
INFINIX-CCI
K113052
Toshiba America Medical Systems, In.C
Radiology · 40d
Cleared Nov 18, 2011
KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
K112132
Medicatech USA
Radiology · 115d
Cleared Nov 10, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR
K112558
Samsung Mobile Display Co., Ltd.
Radiology · 69d
Cleared Oct 20, 2011
DIGIVIEW 250
K103348
Kub Technologies, Inc.
Radiology · 339d
Cleared Oct 20, 2011
VIZION DR
K112661
Viztek, LLC
Radiology · 37d
Cleared Oct 04, 2011
FLAATZ 560
K111583
Drtech Corp.
Radiology · 119d
Cleared Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865
Fujifilm Medical System U.S.A., Inc.
Radiology · 92d
Cleared Sep 02, 2011
DIGITAL RADIOGRAPHY
K111682
Canon Inc. -Medical Equipment Group
Radiology · 79d
Cleared Sep 02, 2011
DIGITAL RADIOGRAPHY
K112309
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
K111548
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d
Cleared Aug 02, 2011
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K110801
Direct Digital Imaging Technology (Beijing), Inc.
Radiology · 132d
Cleared Jul 13, 2011
SANTEVIEW
K111312
Sehyun Co., Ltd.
Radiology · 64d
Cleared Jun 02, 2011
REGUIS SIGMA
K103703
Konica Minolta Medical & Graphic, Inc.
Radiology · 164d
Cleared May 27, 2011
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
K111098
Imaging Dynamics Company , Ltd.
Radiology · 37d
Cleared Apr 27, 2011
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K103599
Meridian Medical Systems, LLC
Radiology · 140d
Cleared Apr 20, 2011
SATURN 8000-GS
K110210
New Medical Co., Ltd.
Radiology · 85d
Cleared Mar 29, 2011
DIGITAL RADIOGRAPHY
K103591
Canon Inc. -Medical Equipment Group
Radiology · 112d
Cleared Mar 29, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
K103596
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 111d
Cleared Nov 29, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR
K101590
VATECH Co., Ltd.
Radiology · 175d
Cleared Nov 18, 2010
WIRELESS DR IMAGING OPTION-WDR1
K102615
Ge Medical Systems, LLC
Radiology · 70d
Cleared Aug 03, 2010
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
K101289
Air Techniques, Inc.
Radiology · 88d
Cleared Jul 15, 2010
FLAT PANEL DETECTOR, MODEL FDR D-EVO
K100762
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 120d
Cleared Jan 21, 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
K093427
Fujifilm Medical System U.S.A., Inc.
Radiology · 79d
Cleared Nov 06, 2009
DX-D IMAGING PACKAGE
K092669
Agfa Healthcare N.V.
Radiology · 67d