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
Cleared
Dec 01, 2010
LLX240AB01
Samsung Mobile Display Co., Ltd.
Radiology
83d
Cleared
Nov 29, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR
VATECH Co., Ltd.
Radiology
175d
Cleared
Nov 18, 2010
WIRELESS DR IMAGING OPTION-WDR1
Ge Medical Systems, LLC
Radiology
70d
Cleared
Aug 17, 2010
DIGITAL RADIOGRAPHY
Canon Inc. -Medical Equipment Group
Radiology
32d
Cleared
Aug 09, 2010
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717
E-Woo Technology
Radiology
480d
Cleared
Aug 03, 2010
SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
Air Techniques, Inc.
Radiology
88d
Cleared
Jul 15, 2010
FLAT PANEL DETECTOR, MODEL FDR D-EVO
Fujifilm Medical Systems U.S.A, Inc.
Radiology
120d
Cleared
Jun 25, 2010
MOBIVISION
Almana Medical Imaging
Radiology
172d
Cleared
Apr 05, 2010
SIMONDR DRP
Simondr, Inc.
Radiology
116d
Cleared
Jan 21, 2010
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
Fujifilm Medical System U.S.A., Inc.
Radiology
79d
Cleared
Nov 06, 2009
DX-D IMAGING PACKAGE
Agfa Healthcare N.V.
Radiology
67d
Cleared
Oct 30, 2009
DIRECT DIGITIZER, REGIUS MODEL 210
Konica Minolta Medical & Graphic, Inc.
Radiology
57d
Cleared
Sep 18, 2009
DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A
Samsung Mobile Display Co., Ltd.
Radiology
182d
Cleared
Aug 11, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
Agfa Healthcare N.V.
Radiology
19d
Cleared
Jun 30, 2009
IDR
Icrco, Inc.
Radiology
309d
Cleared
Jun 15, 2009
DIGITAL RADIOGRAPHY CXDI-60C
Canon, Inc.
Radiology
19d
Cleared
May 29, 2009
DIGITAL RADIOGRAPHY MODEL CXDI-55G
Canon, Inc.
Radiology
15d
Cleared
May 29, 2009
DIGITAL RADIOGRAPHY, MODEL CXDI-55C
Canon, Inc.
Radiology
15d
Cleared
May 18, 2009
WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
Direct Digital Imaging Technology (Beijing), Inc.
Radiology
129d
Cleared
May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
Agfa Healthcare N.V.
Radiology
66d
Cleared
Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
Carestream Health, Inc.
Radiology
56d
Cleared
Mar 24, 2009
CPI RAD VISION, MODEL VZW2944XX-YY
Communications & Power Industries Canada, Inc.
Radiology
141d
Cleared
Mar 24, 2009
DIGITAL RADIOGRAPHY CXDI-40G COMPACT
Canon USA, Inc.
Radiology
15d
Cleared
Mar 24, 2009
WIRELESS PORTABLE DETECTOR FD-W17
Philips Medical Systems North America Co.
Radiology
15d