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
265–288 of 424
Cleared Jan 01, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
K122919
Rayence Co., Ltd.
Radiology · 99d
Cleared Dec 20, 2012
AEROPILOT
K123499
Konica Minolta Medical & Graphic, Inc.
Radiology · 37d
Cleared Dec 07, 2012
DDRVERSA MOTION
K123005
Swissray Medical AG
Radiology · 71d
Cleared Nov 28, 2012
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR
K122495
Perkinelmer, Inc.
Radiology · 104d
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
DX-D IMAGING PACKAGE
K121095
Agfa Healthcare N.V.
Radiology · 127d
Cleared Aug 16, 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
K122182
Rayence Co., Ltd.
Radiology · 24d
Cleared Jul 20, 2012
CR 10-X DIGITIZER
K121948
Agfa Healthcare N.V.
Radiology · 17d
Cleared Jul 11, 2012
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
K121838
Liebel-Flarsheim
Radiology · 19d
Cleared Jun 14, 2012
FUSION FLAT PANEL
K113449
Icrco, Inc.
Radiology · 206d
Cleared May 22, 2012
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K112527
Meridian Medical Systems, LLC
Radiology · 265d
Cleared May 10, 2012
EZSENSOR P DIGITAL INTRAORAL SENSOR
K121132
Humanray Co,Ltd
Radiology · 27d
Cleared May 04, 2012
VIVIX-S
K120020
Vieworks Co., Ltd.
Radiology · 122d
Cleared May 03, 2012
ATAL-8
K113812
Atlaim
Radiology · 132d
Cleared Apr 23, 2012
FLAT PANEL DETECTOR
K111824
Canon Inc. -Medical Equipment Group
Radiology · 300d
Cleared Apr 09, 2012
AEROSYNC FOR AERODR SYSTEM
K120477
Konica Minolta Medical & Graphic, Inc.
Radiology · 53d
Cleared Apr 06, 2012
EOS
K120721
Eos Imaging
Radiology · 29d
Cleared Mar 09, 2012
SATURN 8000
K120380
New Medical Co., Ltd.
Radiology · 31d
Cleared Feb 10, 2012
REGIUS SIGMA2
K120131
Konica Minolta Medical & Graphic, Inc.
Radiology · 24d
Cleared Jan 31, 2012
UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
K111305
Meridian Medical Systems, LLC
Radiology · 267d
Cleared Dec 29, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630
Rayence Co., Ltd.
Radiology · 21d
Cleared Nov 23, 2011
SDX-4343CS
K112751
Samsung Mobile Display Co., Ltd.
Radiology · 63d