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
217–240 of 424
Cleared Oct 16, 2014
DX-D IMAGING PACKAGE
K142184
Agfa Healthcare N.V.
Radiology · 69d
Cleared Oct 03, 2014
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
K141743
Radiology Solutions, LLC
Radiology · 95d
Cleared Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 94d
Cleared Sep 26, 2014
AERODR SYSTEM 2
K141271
Konica Minolta, Inc.
Radiology · 134d
Cleared Sep 12, 2014
DX-D IMAGING PACKAGE
K141602
Agfa Healthcare N.V.
Radiology · 88d
Cleared Aug 29, 2014
DICOMPACS DX-R WITH FLAT PANEL
K141440
Oehm Und Rehbein GmbH
Radiology · 88d
Cleared Aug 27, 2014
OPAL CHIRO, 20/20 P-DR
K141435
2020 Imaging
Radiology · 89d
Cleared Aug 01, 2014
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
K140551
Perkinelmer, Inc.
Radiology · 150d
Cleared Jul 25, 2014
PHILIPS PROGRADE
K141736
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Jul 17, 2014
DELWORKS DR SYSTEM
K140825
Del Medical, Inc.
Radiology · 107d
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
K141563
Rayence Co., Ltd.
Radiology · 34d
Cleared Jul 16, 2014
SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
K141566
Rayence Co., Ltd.
Radiology · 34d
Cleared Jul 01, 2014
DIGITAL RADIOGRAPHY CXDI-401C WIRELESS
K133693
Canon, Inc.
Radiology · 210d
Cleared Jun 06, 2014
DR 400
K141192
Agfa Healthcare N.V.
Radiology · 29d
Cleared May 15, 2014
XGEO GR40CW
K140235
Samsung Electronics Co., Ltd.
Radiology · 105d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR
K140056
Rayence Co., Ltd.
Radiology · 123d
Cleared May 13, 2014
DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A
K140060
Rayence Co., Ltd.
Radiology · 123d
Cleared Apr 25, 2014
PHILIPS ELEVA WORKSPOT
K140771
Philips Medical Systems Dmc GmbH
Radiology · 29d
Cleared Apr 16, 2014
PVMED DDR 2430T
K133524
Portavision Medical, LLC
Radiology · 152d
Cleared Apr 11, 2014
DIGITAL FLAT PANEL X-RAY DETECTOR / 1717G, XMARU1717G
K140646
Rayence Co., Ltd.
Radiology · 29d
Cleared Apr 03, 2014
VIZION ULTRA
K133139
Viztek, LLC
Radiology · 168d
Cleared Mar 21, 2014
NOVA FA DR SYSTEM
K133782
Sedecal., Sa.
Radiology · 99d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442
Carestream Health, Inc.
Radiology · 119d
Cleared Feb 21, 2014
FLAATZ 600 SERIES (FLAATZ 600/601)
K132842
Drtech Corp.
Radiology · 164d