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 Dec 01, 2010
LLX240AB01
K102587
Samsung Mobile Display Co., Ltd.
Radiology · 83d
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 17, 2010
DIGITAL RADIOGRAPHY
K102012
Canon Inc. -Medical Equipment Group
Radiology · 32d
Cleared Aug 09, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
K091090
E-Woo Technology
Radiology · 480d
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 Jun 25, 2010
MOBIVISION
K100001
Almana Medical Imaging
Radiology · 172d
Cleared Apr 05, 2010
SIMONDR DRP
K093790
Simondr, Inc.
Radiology · 116d
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
Cleared Oct 30, 2009
DIRECT DIGITIZER, REGIUS MODEL 210
K092717
Konica Minolta Medical & Graphic, Inc.
Radiology · 57d
Cleared Sep 18, 2009
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
K090742
Samsung Mobile Display Co., Ltd.
Radiology · 182d
Cleared Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
K092238
Agfa Healthcare N.V.
Radiology · 19d
Cleared Jun 30, 2009
IDR
K082450
Icrco, Inc.
Radiology · 309d
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
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K090062
Direct Digital Imaging Technology (Beijing), Inc.
Radiology · 129d
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
CPI RAD VISION, MODEL VZW2944XX-YY
K083224
Communications & Power Industries Canada, Inc.
Radiology · 141d
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