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
Jan 01, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
Rayence Co., Ltd.
Radiology
99d
Cleared
Dec 20, 2012
AEROPILOT
Konica Minolta Medical & Graphic, Inc.
Radiology
37d
Cleared
Dec 07, 2012
DDRVERSA MOTION
Swissray Medical AG
Radiology
71d
Cleared
Nov 28, 2012
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
Perkinelmer, Inc.
Radiology
104d
Cleared
Oct 19, 2012
DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC
Rayence Co., Ltd.
Radiology
88d
Cleared
Oct 09, 2012
RADREX-I, SW V4.00 MODEL DRAD-3000E
Toshiba America Medical Systems, In.C
Radiology
22d
Cleared
Aug 28, 2012
FDR GO FLEX
Fujifilm Medical System U.S.A., Inc.
Radiology
180d
Cleared
Aug 16, 2012
DX-D IMAGING PACKAGE
Agfa Healthcare N.V.
Radiology
127d
Cleared
Aug 16, 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
Rayence Co., Ltd.
Radiology
24d
Cleared
Jul 20, 2012
CR 10-X DIGITIZER
Agfa Healthcare N.V.
Radiology
17d
Cleared
Jul 11, 2012
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
Liebel-Flarsheim
Radiology
19d
Cleared
Jun 14, 2012
FUSION FLAT PANEL
Icrco, Inc.
Radiology
206d
Cleared
May 22, 2012
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
Meridian Medical Systems, LLC
Radiology
265d
Cleared
May 10, 2012
EZSENSOR P DIGITAL INTRAORAL SENSOR
Humanray Co,Ltd
Radiology
27d
Cleared
May 04, 2012
VIVIX-S
Vieworks Co., Ltd.
Radiology
122d
Cleared
May 03, 2012
ATAL-8
Atlaim
Radiology
132d
Cleared
Apr 23, 2012
FLAT PANEL DETECTOR
Canon Inc. -Medical Equipment Group
Radiology
300d
Cleared
Apr 09, 2012
AEROSYNC FOR AERODR SYSTEM
Konica Minolta Medical & Graphic, Inc.
Radiology
53d
Cleared
Apr 06, 2012
EOS
Eos Imaging
Radiology
29d
Cleared
Mar 09, 2012
SATURN 8000
New Medical Co., Ltd.
Radiology
31d
Cleared
Feb 10, 2012
REGIUS SIGMA2
Konica Minolta Medical & Graphic, Inc.
Radiology
24d
Cleared
Jan 31, 2012
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
Meridian Medical Systems, LLC
Radiology
267d
Cleared
Dec 29, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
Rayence Co., Ltd.
Radiology
21d
Cleared
Nov 23, 2011
SDX-4343CS
Samsung Mobile Display Co., Ltd.
Radiology
63d