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
169–192 of 424
Cleared Jun 11, 2013
DR LONG LENGTH IMAGING SOFTWARE
K130567
Carestream Health, Inc.
Radiology · 99d
Cleared Jun 07, 2013
CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
K130464
Carestream Health, Inc.
Radiology · 105d
Cleared Mar 12, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K123345
Rayence Co., Ltd.
Radiology · 132d
Cleared Jan 30, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K122928
Rayence Co., Ltd.
Radiology · 128d
Cleared Jan 01, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
K122919
Rayence Co., Ltd.
Radiology · 99d
Cleared Oct 19, 2012
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
K122173
Rayence Co., Ltd.
Radiology · 88d
Cleared Oct 09, 2012
RADREX-I, SW V4.00 MODEL DRAD-3000E
K122842
Toshiba America Medical Systems, In.C
Radiology · 22d
Cleared Aug 28, 2012
FDR GO FLEX
K120629
Fujifilm Medical System U.S.A., Inc.
Radiology · 180d
Cleared Aug 16, 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
K122182
Rayence Co., Ltd.
Radiology · 24d
Cleared Dec 29, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630
Rayence Co., Ltd.
Radiology · 21d
Cleared Nov 22, 2011
INFINIX-CCI
K113052
Toshiba America Medical Systems, In.C
Radiology · 40d
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 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 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 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 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 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 Sep 12, 2008
DRAD3000E/RADREX-I
K082494
Toshiba America Medical Systems, In.C
Radiology · 14d